[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-failure":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,47,78,112,136,176,200,246,285,318,346,372,395,422,454,477,504,540,566,592,621,645,669,695,715],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100565470","starting-incremental-prescription-of-peritoneal-dialysis-100565470",false,"NCT06642597","STarting incrEmental Prescription of Peritoneal Dialysis","An International, Multi-centre, Randomised Controlled Trial Co-designed With Consumers With Lived Experience of Peritoneal Dialysis (PD) to Determine the Optimal Approach to Starting Patients With Kidney Failure on PD","STEP-PD","Inclusion Criteria:\n\n* adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for \\\u003C1 month)\n* able to give informed consent\n\nExclusion Criteria:\n\n* urine output \\\u003C0.5L\u002Fday\n* previous kidney transplant\n* unlikely to be on dialysis for ≥1 year.\n* known or planned pregnancy during the trial","ALL","18 Years",{"count":20,"type":21},224,"ESTIMATED","INTERVENTIONAL",[24],"NA","Kidney failure is fatal without dialysis. Peritoneal dialysis (PD) completed at home offers greater flexibility and autonomy for patients . However, PD is often prescribed for 24 hours\u002Fday, 7 days\u002Fweek for every patient starting dialysis. This practice is not evidence-informed, may be unnecessary and potentially harmful. The STEP-PD trial aims to determine the optimal approach to commencing patients on PD through starting at low dose PD and incrementing over time.",[27,28],"Peritoneal Dialysis (PD)","Kidney Failure",[30,31,32,33],"Kidney failure","Kidney disease","peritoneal dialysis","incremental start PD","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":38},"2025-09-19",{"date":42,"type":21},"2029-09-30",{"name":44,"class":45},"The University of Queensland","OTHER",9,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100590795","early-phase-1-tolerance-through-mixed-chimerism-sip-tego-100590795","NCT06972069","Tolerance Through Mixed Chimerism (Sip-Tego)","Recipient Inclusion Criteria:\n\n1. Male or female 18-65 years of age.\n2. Subjects with chronic kidney disease stage V (GFR\\\u003C15ml\u002Fmin\u002F1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.\n3. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor\n4. First or second renal transplant.\n5. EBV Seropositive\n6. Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation\n7. Ability to understand and provide informed consent.\n8. Negative COVID-19 test during screening and two days prior to procedure\n\nRecipient Exclusion Criteria:\n\n1. ABO blood group-incompatible renal allograft\n2. Participant with a donor-specific antibody (DSA) within 6 months prior to transplant\n3. Persistent Leukopenia (WBC less than 2,000\u002Fmm3) or thrombocytopenia (\\\u003C100,000\u002Fmm3)\n4. Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.\n5. Untreated Infection\n6. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n7. Forced expiratory volume FEV1 or DLCO \\\u003C 50% of predicted.\n8. Lactation or pregnancy.\n9. Patients with active cancer or those with a high risk of recurrence following the American Transplant Society\n10. Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as non-genetic primary focal segmental glomerulosclerosis dense deposit disease, C3 glomerulonephritis, and, atypical hemolytic uremic syndrome).\n11. Prior dose-limiting radiation therapy for treatment of malignant disease.\n12. Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen. This includes long term cigarette smoking or a family history of malignancy.\n13. Enrollment in other investigational drug studies within 30 days prior to enrollment.\n14. Abnormal (\\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT) , or any patients on chronic anticoagulation therapy.\n15. Allergy or sensitivity to any component of Cyclophosphamide, tacrolimus, Siplizumab, Tegoprubart, or rituximab.\n16. The presence of any medical condition that the investigator deems incompatible with participation in the trial. This includes a history of alcohol abuse or illicit drug use\u002Fdependence.\n17. Any chronic or intermittent administration of immunosuppressant medication (such as for inflammatory bowel disease or asthma)\n18. Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\\\u003C8%). Subjects with severe diabetes-related complications, such as advanced retinopathy, gastroparesis, or severe neuropathy that significantly impair their ability to perform normal, independent daily activities, will also be excluded.\n\nDonor Inclusion Criteria:\n\n1. Male or female 18-70 years of age.\n2. For females of childbearing potential: a serum pregnancy test showing negative results.\n3. Excellent health per conventional pre-donor workup (medical and psychosocial evaluation)\n4. Acceptable laboratory parameters (hematology in normal or near-normal range; Liver function \\\u003C2 times the upper limit of normal, and normal creatinine).\n5. Negative for viral infection with HBV (HbsAg and NAT), HIV (antibody and NAT), HCV (NAT), or HTLV-1.\n6. Cardiac\u002Fpulmonary function within normal limits (CXR, ECG).\n7. Ability to understand and provide informed consent.\n8. Meets standard institutional criteria for bone marrow aspiration and kidney donation.\n9. Negative COVID-19 test during screening and two days prior to procedure","65 Years",{"count":55,"type":21},12,[57],"EARLY_PHASE1","This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.",[28,60,61,62,63],"Transplant Recipient (Kidney)","Transplant Tolerance","Immunosuppresion","Immunosuppression After Kidney Transplantation",[65,66,67],"Tolerance","Transplant without immunosuppression","kidney transplant","2026-06-05",{"date":70,"type":38},"2026-06-08",{"date":72,"type":38},"2025-05-31",{"date":74,"type":21},"2030-12-31",{"name":76,"class":45},"Tatsuo Kawai, MD, PhD",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100520402","phase-1-car-t-cell-therapy-for-desensitization-in-kidney-transplantation-100520402","NCT06056102","CAR-T Cell Therapy for Desensitization in Kidney Transplantation","Autologous Chimeric Antigen Receptor Engineered T Cell Immunotherapy for Desensitization in Patients Awaiting Kidney Transplantation","Inclusion Criteria:\n\n1. Male or female patients aged 18-65 years with kidney failure requiring hemodialysis.\n2. Patients must meet one of the following two criteria:\n\n   1. All the following:\n\n      * Protocol-specific cPRA ≥99.5%\n      * No suitable living donor OR has been active in a kidney paired donation program but not received a match within 12 months\n      * Have blood group Type O or B, and predictive of a positive virtual crossmatch to an available deceased donor.\n      * United Network for Organ Sharing (UNOS) listed for kidney transplant for at least 1 year\n   2. Protocol-specific cPRA ≥99.9% Protocol-specific cPRA must be rounded from three significant figures measured ≤90 days from the time of enrollment (i.e., cPRA of 0.994500 or 0.998500 would be eligible) using the web-based OPTN cPRA calculator (https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fresources\u002Fallocation-calculators\u002Fcpra-calculator\u002F); accounting for HLA-A, -B, -C, -DRB1, -DRB3\u002F4\u002F5, and -DQB1 Luminex Single Antigen Beads (SAB) with MFI ≥3000; 1 archived sample within 6 months of screening required.\n3. Based on center-specific listing policies, a cPRA in UNet Waitlist that is ≥99.5% (the candidate must be eligible for additional priority of kidneys equivalent to individuals with a 100% cPRA)\n4. Able to understand and give written informed consent to participate in all aspects of the study.\n5. Willing to stay within 2 hours of the home study site for at least 28 days after the last T cell infusion\n6. Subjects of reproductive potential must agree to use contraception for at least one year after CAR T Cell infusion\n7. In the absence of contraindication, vaccinations must be up to date per the DAIT Guidance for Patients in Transplant Trials and include TdAP\n8. Positive for EBV capsid IgG\n9. Negative testing for latent TB infection within 3 months prior to enrollment. Testing should be conducted using either a PPD or interferon-gamma release assay (i.e. QuantiFERON-TB, T-SPOT.TB). Patients with a positive test for latent TB infection must complete appropriate therapy for Latent Tuberculosis Infection (LTBI). A subject is considered eligible only if they have a negative test for LTBI within 3 months prior to enrollment OR they have appropriately completed LTBI therapy prior to transplant. Latent TB infection treatment regimens should be among those endorsed by the CDC\n10. Hemoglobin ≥9g\u002FdL\n11. ANC ≥ 1,800\u002FμL, \\> 1,200\u002F μL for patients with Duffy-null associated neutrophil count (DANC)\n12. Absolute Lymphocyte Counts ≥500\u002FμL or CD3 T cell Count ≥150\u002FμL\n13. Platelet count ≥120,000\u002FμL\n\nExclusion Criteria:\n\n1. Subjects with indwelling catheters as primary access for hemodialysis\n2. Previous solid organ (except kidney) or bone marrow transplant\n3. BMI ≥35 kg\u002Fm\\^2\n4. Subjects who have preserved or oliguric urine output \\> 100 cc\u002Fday with history of recurrent UTI (2 in 6 months or 3 in 1 year, see study definitions)\n5. Subjects described in exclusion #4 with structural disease such as polycystic kidney disease, obstructive uropathy with nephrolithiasis or those otherwise at higher risk of urinary tract infections. Anuric subjects with structural kidney disease are not excluded\n6. Known active current or history of invasive fungal infection; any non-tuberculous mycobacterial infection that has been active or has required therapy within the last year. Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or PO antibiotics within 2 weeks\n7. History of HIV, chronic HBV, or chronic HCV, regardless of treatment\n8. Negative CMV serology\n9. Detectible viral load HBV, HCV, CMV, EBV, or BK by PCR\n10. Any B cell depleting or monoclonal antibody therapy within 6 months prior to enrollment\n11. Receiving ongoing immunosuppression including corticosteroids \\>5mg\u002Fday, intravenous immunoglobulin, cyclophosphamide, tacrolimus, mycophenolic acid, or azathioprine from 30 days prior to study entry\n12. Active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the investigator) autoimmune disease requiring prolonged immunosuppressive therapy, except Systemic Lupus Erythematosus that has been managed with a stable low dose of prednisone (5mg or less for at least 8 weeks) without other immunosuppressants or targeted biologics; or for renal-limited autoimmune conditions without risk for systemic manifestations (e.g. IgA nephropathy)\n13. Any chronic illness requiring uninterrupted anti-coagulation or anti-platelet therapy\n14. History of cirrhosis or severe liver disease, including abnormal liver profile (aspartate aminotransferase \\[AST\\], alanine aminotransferases \\[ALT\\] or total bilirubin \\> 3 times upper limit of normal at screening (except for patients in whom hyperbilirubinemia is attributed to Gilbert's syndrome)\n15. History of sickle cell disease, or systemic amyloidosis\n16. Cardiac clearance for transplant \\> 6 months old and\u002For any of the following: NYHA Class III or IV heart failure, unstable angina, left ventricular ejection fraction \\\u003C 40%, a history of recent (within 6 months) myocardial infarction or implantable cardioverter\u002F defibrillators and\u002For biventricular pacing.\n17. Moderate-severe pulmonary function abnormality, defined as resting oxygen saturation \\\u003C92% on room air or FEV1, TLC, or DLCO (after correction for hemoglobin) \\\u003C50% of predicted values\n18. Patients who have received any live vaccine within 30 days of planned leukapheresis\n19. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening\n20. Pregnant, currently breastfeeding, or planning to become pregnant during the primary or post-transplant follow up of the study.\n21. Past or current social or medical problems; or findings from physical examination or laboratory testing that are not listed above, which in the opinion of investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n\nLymphodepleting Chemotherapy Eligibility:\n\nStudy entry eligibility must be re-assessed prior to starting lymphodepletion. In addition, subjects must undergo respiratory viral testing on nasal or nasopharyngeal swabs (per institutional practice) for SARS-CoV-2 and influenza within 7 days prior to the first planned lymphodepletion chemotherapy.\n\n1. If the subject is positive for influenza, Tamiflu® or equivalent should be administered per package insert. The subject must complete treatment and symptoms must be improving and either resolved or nearly resolved in the judgment of the treating investigator prior to receiving lymphodepleting chemotherapy and CAR T cells. Repeat influenza testing is not required prior to initiating lymphodepleting chemotherapy and CAR T cell infusion.\n2. If the subject tests positive for SARS-CoV-2, the subject will be managed per institutional practice. Subject will be eligible to initiate lymphodepleting chemotherapy and CAR T cell infusion once cleared from requirement for isolation according to institutional and\u002For CDC guidance.\n3. If testing is positive for another respiratory virus (e.g., as part of a multiplex respiratory pathogen panel in the course of testing for influenza or SARS-CoV-2), the lymphodepleting chemotherapy and CAR T cell infusion will be delayed for at least 7 days to be sure clinical symptoms of a viral infection do not develop. If clinical symptoms develop, the lymphodepleting chemotherapy and CAR T cell infusion will be delayed until resolution of these symptoms.\n\nCAR T Cell Infusion Eligibility:\n\nThe criteria below will be assessed by the investigator following lymphodepleting chemotherapy and before administration of CAR T cells. Subjects who do not satisfy these criteria may have CAR T cell infusion delayed until such time as criteria are satisfied. Subjects who receive lymphodepleting chemotherapy but in whom CAR T cell infusion is delayed \\>4 weeks after the first day of lymphodepleting chemotherapy will receive a second cycle of lymphodepleting chemotherapy prior to CAR T cell infusion. For subjects receiving fludarabine, a second cycle of cyclophosphamide can be administered, but fludarabine will not be repeated.\n\n1. Subjects must not have developed deterioration in performance status or overall clinical condition or new laboratory abnormalities that would, in the opinion of the treating investigator, render it unsafe to proceed with CAR T cell infusion. The following are specific conditions that warrant delaying CAR T cell infusion:\n\n   1. Requirement for supplemental oxygen to maintain peripheral oxygen saturation ≥95%.\n   2. Presence of clinically significant radiographic abnormalities on chest x-ray. Chest x-ray is not required to evaluate for radiographic abnormalities in the absence of suggestive symptoms or exam findings.\n   3. New cardiac arrhythmia not controlled with medical management. EKG is not required to evaluate for arrhythmia in the absence of suggestive symptoms or exam findings.\n   4. Hypotension requiring vasopressor support.\n   5. Active infection: Diagnostic test results indicating new bacterial, fungal, or viral infection within prior 48 hours.\n2. Subjects must have adhered to restrictions on pre-infusion therapy.",{"count":86,"type":21},20,[88],"PHASE1","This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA.\n\nThe main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell.\n\nThe primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and\u002For recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.",[91,28,92],"Kidney Transplant","End Stage Renal Failure on Dialysis",[94,95,96,97,98,99,100],"Kidney transplant","CART-BCMA","huCART-19","Highly sensitized","cPRA","UNOS waiting list","End stage renal failure patients with cPRA >99.5%","2026-05-19",{"date":103,"type":38},"2026-05-22",{"date":105,"type":38},"2024-05-09",{"date":107,"type":21},"2042-12-15",{"name":109,"class":110},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",3,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100434055","incremental-dialysis-to-improve-health-outcomes-in-people-starting-haemodialysis-inch-hd-100434055","NCT04932148","INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)","The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥ 18 years of age) and\n2. Commencing HD as their initial dialysis therapy and\n3. Able to give informed consent\n\nExclusion Criteria:\n\n1. Urine output \\\u003C0.5Litres\u002Fday\n2. Unlikely to be on HD for ≥1 year.",{"count":120,"type":21},372,[24],"The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.",[28],[125,126],"Incremental HD","Incident HD","2026-05-10",{"date":129,"type":38},"2026-05-13",{"date":131,"type":38},"2022-07-06",{"date":133,"type":21},"2026-08",{"name":44,"class":45},18,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":159,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":77},"100627258","kidney-transplant-improvement-through-new-exercise-training-to-increase-capacity-100627258","NCT07446296","Kidney Transplant Improvement Through New Exercise Training to Increase Capacity","KINETIC -- Kidney Transplant Improvement Through New Exercise Training to Increase Capacity","KINETIC","Inclusion Criteria:\n\n* be at least 60 years old\n* receive transplant care at Penn Medicine\n* be on the kidney transplant waiting list\n* speak and comprehend English\n* be able to walk\n* have at least one physical function limitation OR at least one frailty metric\n* have access to a device capable of connecting to the Internet and downloading an application\n* be able to provide written informed consent\n* be cleared for participant via the Physical Activity Readiness Questionnaire (PARQ) verified against medical record or via written medical clearance from a clinician\n\nExclusion Criteria:\n\n* Have had a myocardial infarction or a stroke in the 3 months immediately prior to enrollment\n* Be unable to self-monitor with study devices (i.e., have a condition such as dementia)\n* Not cleared by PARQ or receive written medical clearance to exercise\n* Participate in another physical activity study\n* Have any other reason they do not expect to be able to complete the study","60 Years",{"count":146,"type":21},60,[24],"The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants.\n\nThe main questions it aims to answer are:\n\n* Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list?\n* Do participants follow the exercise program and wear a physical activity tracker as asked?\n* Is the program safe and well tolerated?\n\nResearchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function:\n\n* Usual pre-transplant care with a physical activity tracker\n* Usual pre-transplant care plus an online exercise program\n\nParticipants will:\n\n* Wear a wrist activity tracker to measure daily physical activity\n* Complete a one-week baseline period before being assigned to a study group\n* Be randomly assigned (like flipping a coin) to one of two groups\n* If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback\n* Answer questionnaires about their health, activity, and experience in the study\n\nThis study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.",[150,151,28,152,153,154,155,156,157,158],"Chronic Kidney Disease 5D","Chronic Kidney Disease Stage 5","Kidney Failure,Chronic","Renal Insufficiency Chronic","Chronic Kidney Disease Stage 4","Kidney Transplantation","Waiting List","Transplant Candidate","Exercise Theraphy",[160,161,162,163,164,165,166],"kidney transplant candidates","prehabilitation","home-based exercise","physical activity program","kidney transplant waiting list","pre-transplant care","physical function","2026-05-05",{"date":169,"type":38},"2026-05-06",{"date":171,"type":38},"2026-03-24",{"date":173,"type":21},"2028-05",{"name":175,"class":45},"University of Pennsylvania",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":199},"100542504","a-high-protein-egg-white-pudding-for-people-with-kidney-failure-hipe-kf-100542504","NCT06343727","A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial\n* Male or female aged ≥18 years with CKD\n* On chronic in-center hemodialysis for \\> 3 months\n* Serum albumin \\\u003C35 g\u002FL\n* No expected change in dialysis modality or relocation outside of Winnipeg during the intervention period (12 weeks)\n\nExclusion Criteria:\n\n* Allergy to eggs\n* History of renal transplant\n* Serum albumin ≥ 35 g\u002FL\n* Bowel diseases\n* Cancer\n* Pregnancy\n* Receiving chemotherapy treatment\n* Inability to consume treatment product\n* Allergy to study treatment ingredients\n* Planning on starting an exercise program during the duration of the trial\n* Inability to obtain written informed consent",{"count":183,"type":21},54,[24],"The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:\n\n* To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.\n* To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.\n* To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.",[28,187,188],"Frailty","Kidney Disease, Chronic","2026-04-17",{"date":191,"type":38},"2026-04-22",{"date":193,"type":38},"2025-07-25",{"date":195,"type":21},"2026-10-01",{"name":197,"class":198},"Seven Oaks Hospital Chronic Disease Innovation Centre","NETWORK",2,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":212,"conditions":213,"keywords":217,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100372345","phase-3-shingrix-in-renal-transplant-recipients-100372345","NCT04128189","Shingrix in Renal Transplant Recipients","Safety and Immunogenicity of Shingrix in Renal Transplant Recipients","Study Population:\n\nAdults with chronic kidney failure who are listed for kidney transplantation at participating transplant centers.\n\nInclusion Criteria:\n\nAge 18 to 70 years Able and willing to provide written informed consent Currently on the waiting list for kidney transplantation at a participating institution, with anticipated transplantation occurring between \\>3 and 24 months after the first dose of Shingrix\n\nEither:\n\nEligible to receive Shingrix at study entry per CDC-recommended schedule, or Previously completed the Shingrix vaccination series within 3 to 24 months prior to study entry Female participants of non-childbearing potential (e.g., tubal ligation, hysterectomy, ovariectomy, or post-menopausal ≥12 months)\n\nFemale participants of childbearing potential must:\n\nUse adequate contraception for at least 30 days prior to vaccination Have a negative pregnancy test on the day of each vaccination Agree to continue adequate contraception during the study and for 2 months after completing the vaccination series Be considered by the investigator likely to comply with study requirements\n\nExclusion Criteria:\n\nActive immunosuppressive or immunodeficient condition (e.g., malignancy, HIV infection) or receipt of immunosuppressive therapy within 3 months prior to planned vaccination that, in the investigator's opinion, may interfere with vaccine response History of herpes zoster (shingles) within the past 3 years Receipt of varicella vaccine within 3 years prior to study entry Known allergy to any component of the Shingrix vaccine Receipt of investigational drugs within 30 days prior to enrollment or planned use during the study Receipt of non-live vaccines within 2 weeks prior to any Shingrix dose or planned within 30 days after vaccination Receipt of live vaccines within 4 weeks prior to any Shingrix dose or planned within 30 days after vaccination Pregnant or breastfeeding Planned or prior multi-organ transplantation Residence or travel distance greater than 2 hours from the study site, which would interfere with study visits or timely processing of blood samples","70 Years",{"count":209,"type":21},132,[211],"PHASE3","The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection.\n\nThe main questions it aims to answer are:\n\nHow strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant?\n\nDoes a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose?\n\nHow long does protection from the vaccine last before and after transplant?\n\nHow safe is the vaccine in this group, including whether it affects transplant-related immune markers?\n\nResearchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection.\n\nParticipants will:\n\nBe screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining\n\nIf they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose\n\nComplete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits\n\nTake part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research\n\nShingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.",[214,28,215,155,216],"Kidney Transplant Recipient Response to Shingrix Vaccine","Kidney Failure, Chronic","Herpes Zoster (HZ)",[218,219,220,221,222,28,223,224,91,225,226,227,228,229,230,231,232,233,234,235],"Shingrix","Recombinant Zoster Vaccine","Herpes Zoster Vaccine","Herpes Zoster","Shingles","Chronic Kidney Disease","Renal Failure","Renal Transplantation","Transplant Candidates","Immunocompromised","Immunogenicity","Vaccine Response","Cellular Immunity","T Cell Response","Booster Dose","Vaccine Durability","Post-Transplant Immunity","Vaccine Safety","2026-04-02",{"date":238,"type":38},"2026-04-08",{"date":240,"type":38},"2023-03-02",{"date":242,"type":21},"2029-06",{"name":244,"class":45},"University of Colorado, Denver",4,{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":254,"targetDuration":4,"studyType":256,"phases":4,"briefSummary":257,"conditions":258,"keywords":264,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":77},"100630810","renal-and-hepatic-abnormal-doppler-patterns-in-trauma-100630810","NCT07492511","Renal and Hepatic Abnormal Doppler Patterns in Trauma","Renal and hEpatiC abnoRmal dopplEr pAtterns iN Trauma: a Multicentre Prospective Observational Study","RECREANT","Inclusion Criteria:\n\n* Age 18-65 years;\n* Admission within 24h from traumatic injury;\n* ISS \\>15\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>65;\n2. Known heart failure (NYHA ≥II);\n3. Chronic kidney disease (any stage) or chronic RRT;\n4. Chronic respiratory disease needing home O₂ or ventilation;\n5. Radiological evidence of vascular or parenchymal renal injury on trauma CT precluding reliable Doppler assessment",{"count":255,"type":21},350,"OBSERVATIONAL","The goal of this observational study is to learn about renal and hepatic blood flow abnormalities detected by bedside ultrasound in adult patients admitted to the intensive care unit (ICU) following major trauma.\n\nThe main questions it aims to answer are:\n\n* How reliably can trained operators measure renal Doppler and venous congestion scores (RDRI and VExUS) across different hospitals?\n* How common are abnormal kidney and liver blood flow patterns in major trauma patients during the first 72 hours of ICU admission?\n* Are these abnormal patterns associated with acute kidney injury or the need for mechanical ventilation?\n\nParticipants admitted to ICUs or high-dependency units (HDUs) with major trauma (Injury Severity Score \\>15) will undergo non-invasive bedside ultrasound assessments at admission and at 24, 48, and 72 hours. No additional treatments or interventions will be given as part of this study. Kidney function will also be checked at 6 months after hospital discharge.",[259,260,261,262,263,28],"Trauma (Including Fractures)","Trauma Patients","Kidney Disease","Hypovolemia","Hypervolemia",[265,266,267,268,269,270,271,272,273,274],"VEXUS","trauma","kidney injury","kidney failure","Venous congestion","renal perfusion","Renal Doppler resistive index","major trauma","Hemodynamic phenotyping","ICU","2026-03-19",{"date":277,"type":38},"2026-03-25",{"date":279,"type":38},"2026-03-01",{"date":281,"type":21},"2030-06-30",{"name":283,"class":284},"Azienda Usl di Bologna","OTHER_GOV",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":144,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":302,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":4},"100625231","older-kidney-patient-optimisation-pretransplant-100625231","NCT07419945","Older Kidney Patient Optimisation Pretransplant","Optimising Access to and Outcomes From Transplantation in Older Potential Kidney Transplant Recipients: Pilot Feasibility Study on Kidney Transplant-specific Comprehensive Geriatric Assessment (KT-CGA)","OK-POP","Inclusion Criteria:\n\n* Adults aged 60 years or older\n* Attending Guy's and St Thomas' (GSTT) Nephrology services\n* Diagnosed with Chronic Kidney Disease (CKD) Stage 5\n\nEither:\n\n* Pre-dialysis, or\n* Receiving dialysis (in-centre haemodialysis, peritoneal dialysis, or home haemodialysis)\n* Referred to the kidney transplant surgical clinic for assessment of suitability for kidney transplantation (pre-transplant evaluation)\n\nExclusion Criteria:\n\n* Adults aged under 60 years\n* Patients currently attending the Nephrology Supportive Care service at GSTT",{"count":294,"type":21},50,[24],"The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are:\n\nIs it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease?\n\nWhat is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty?\n\nResearchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone.\n\nParticipants will:\n\nContinue with their usual transplant assessment process\n\nIf randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)",[261,28,187,298,299,300,91,301],"Cognitive Impairment","Multimorbidity","End Stage Kidney Disease (ESRD)","Health Inequity",[67,303,304,305,306,307],"frailty","multimorbidity","cognitive impairment","end stage kidney disease","health inequality","NOT_YET_RECRUITING","2026-02-12",{"date":311,"type":38},"2026-02-19",{"date":313,"type":21},"2026-02-02",{"date":315,"type":21},"2028-02-02",{"name":317,"class":45},"Guy's and St Thomas' NHS Foundation Trust",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":77},"100621967","dialysate-cooling-for-the-preservation-of-cognitive-function-in-people-receiving-haemodialysis-100621967","NCT07377500","Dialysate Cooling for the Preservation of Cognitive Function in People Receiving Haemodialysis","Randomised Controlled Trial of Dialysate Cooling for the Preservation of Cognitive Function in People Receiving Haemodialysis","COOL HD","Inclusion Criteria:\n\n* The participant is receiving maintenance in-centre haemodialysis\n* Over 18 years of age at time of consent\n* The participant is able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Participants with confirmed diagnosis of dementia.\n* Participants who lack capacity to consent.\n* Participants having dialysis less than three times a week.\n* Pregnant participants.",{"count":327,"type":21},356,[24],"When a person's kidneys are not working properly, they need a life-saving treatment called haemodialysis three times a week to filter the waste and extra fluids from the blood. 25 000 adults in the United Kingdom are currently having haemodialysis and unfortunately more than two-thirds of these people experience problems with thinking and memory, which may lead to dementia. These problems tend to worsen more rapidly than people who are not on haemodialysis. This decline in brain function can make it harder for people to do everyday tasks, increase their reliance on others, and lower their overall quality of life. It also raises the chances of needing hospital care and can shorten their lifespan.\n\nOne reason for this decline in thinking and memory could be the dialysis treatment itself. Research has shown that blood flow to the brain can drop during dialysis. If this happens regularly, it can harm the brain over time. Earlier studies found that cooling the dialysis fluid slightly (to 0.5°C below body temperature) helped people tolerate dialysis better and showed less brain damage on magnetic imaging brain scans (MRI) after a year, compared to those who had haemodialysis without cooling the dialysis fluid. However, the investigators still don't know if this brain protection translates into better thinking and memory for people on haemodialysis.\n\nThis study will see if cooling the dialysis fluid helps preserve thinking and memory function.\n\nThe investigators will invite participants at three hospitals with haemodialysis centres to take part. Those who agree will be randomly assigned to either standard dialysis or cooled dialysis. The investigators will assess participants' thinking and memory functions using special tests at the start of the study and again after a year. By comparing the results from both groups, the investigators hope to see if the cooled dialysis really helps protect brain.",[331,28],"Haemodialysis",[333,334,335,336],"DIALYSATE COOLING","KIDNEY FAILURE","HAEMODIALYSIS","COGNITIVE IMPAIRMENT","2026-01-30",{"date":339,"type":38},"2026-02-03",{"date":341,"type":21},"2026-04-01",{"date":343,"type":21},"2028-01-01",{"name":345,"class":45},"University Hospitals of Derby and Burton NHS Foundation Trust",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":22,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":371},"100414067","a-study-to-evaluate-the-safety-and-effectiveness-of-the-innavasc-arteriovenous-graft-for-hemodialysis-access-in-patients-with-end-stage-renal-disease-100414067","NCT04671771","A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease","Inclusion Criteria:\n\nPre-Operative Inclusion Criteria:\n\nPatients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:\n\n1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;\n2. Age 18 to 90 years old, inclusive;\n3. Suitable anatomy for implantation of upper arm \"straight\" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);\n4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);\n5. Able and willing to give informed consent;\n6. Anticipated life expectancy of at least 1 year.\n\nIntra-Operative Inclusion Criteria:\n\nBoth vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).\n\nPre-Operative Exclusion Criteria:\n\nPatients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:\n\n1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;\n2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);\n3. For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \\\u003C 18 cm;\n4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);\n5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;\n6. Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;\n7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);\n8. Baseline hemoglobin \\\u003C7 g\u002FdL;\n9. Baseline platelet count \\\u003C50,000 or \\>500,000 cells\u002Fmm3;\n10. Documented history of stroke within 6 months prior to enrollment;\n11. Treatment with any investigational drug or device within 30 days prior to enrollment;\n12. Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);\n13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;\n14. Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;\n15. Documented or suspected hypercoagulable condition;\n16. Bleeding diathesis, other than that associated with ESRD;\n17. Documented history of heparin-induced thrombocytopenia (HIT);\n18. Active local or systemic infection as documented from the medical history or bloodwork\u002Fblood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;\n19. Scheduled renal transplant within 6 months;\n20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;\n21. Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.","90 Years",{"count":354,"type":21},133,[24],"The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are:\n\nPrimary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.\n\nPrimary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months.\n\nParticipants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.",[358,28,359,360],"End Stage Renal Disease (ESRD)","Chronic Renal Disease","Hemodialysis","2025-12-18",{"date":363,"type":38},"2025-12-22",{"date":365,"type":38},"2020-12-03",{"date":367,"type":21},"2029-07-01",{"name":369,"class":370},"W.L.Gore & Associates","INDUSTRY",21,{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":256,"phases":4,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":5},"100534815","a-study-of-maribavir-in-adults-with-kidney-failure-who-have-a-cytomegalovirus-cmv-infection-after-transplantation-100534815","NCT06243731","A Study of Maribavir in Adults With Kidney Failure Who Have a Cytomegalovirus (CMV) Infection After Transplantation","Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Severe Chronic Kidney Disease (CKD) or Comorbid End-stage Renal Disease (ESRD), Including Patients on Peritoneal Dialysis or Hemodialysis","Inclusion Criteria:\n\n* Adults more than and equal to (≥) 18 years of age at index date.\n* Diagnosis of comorbid ESRD or comorbid severe CKD prior to the index date.\n\n  * If ESRD (including participants on peritoneal dialysis or hemodialysis): participant diagnosed with ESRD confirmed by an estimated glomerular filtration rate (eGFR) less than (\\\u003C) 15 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73m\\^2).\n  * If severe CKD: participant diagnosed with severe CKD confirmed by an eGFR of 15 to \\\u003C30 mL\u002Fmin\u002F1.73m\\^2 at index.\n* Participant has undergone solid organ transplant (SOT) or hematopoietic stem cell transplantation (HSCT) before index date.\n* Participant was diagnosed with refractory (with or without resistance) CMV during the latest post-transplant period.\n* Participant initiated treatment with maribavir in routine practice within the eligibility period and received at least 1 dose of maribavir.\n* Informed consent provided (where required by local regulations) before data collection commences.\n\nExclusion Criteria:\n\nThere are no exclusion criteria for this study.",{"count":380,"type":21},10,"The main aim of this study is to assess the safety of maribavir in adults with severe CKD or comorbid ESRD including participants on artificial filtering of the kidney (dialysis) or the blood (hemodialysis).\n\nIn this study, already existing data will be collected from the participant's medical records. The study will only review data collected as part of the normal clinical routine and will not impact the standard medical care and treatment of participants.",[383,261,28],"Cytomegalovirus (CMV)",[385],"Drug therapy","2025-12-08",{"date":388,"type":38},"2025-12-16",{"date":390,"type":38},"2025-11-03",{"date":392,"type":21},"2027-01-31",{"name":394,"class":370},"Takeda",{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":421},"100396884","phase-4-effects-of-the-sglt2-inhibitor-empagliflozin-in-patients-with-euvolemic-and-hypervolemic-hyponatremia-100396884","NCT04447911","Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia","Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)","EMPOWER","Inclusion Criteria:\n\n\\- chronic eu- OR hypervolemic non hyperosmolar (\\\u003C300 mOsm\u002Fkg) hyponatremia (heparin plasma sodium \\\u003C135 mmol\u002FL on day of inclusion)\n\nExclusion Criteria:\n\n* known hypersensitivity or allergy to class of drugs or the investigational product,\n* severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive\u002Fintermediate care treatment at time of inclusion\n* clinical hypovolemia\n* Severe reduction of eGFR \\\u003C20 mL\u002Fmin\u002F1,73 m2 (KDIGO G4 and G5) or end stage renal disease\n* Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …)\n* Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) \\>3x the upper limit of normal (ULN); or total bilirubin \\>2x ULN at time of enrolment\n* uncontrolled hypothyroidism\n* uncontrolled adrenal insufficiency\n* systolic blood pressure \\\u003C90mmHg\n* contraindication for lowering blood pressure\n* diabetes mellitus type 1 or pancreatic diabetes mellitus\n* treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day\n* severe immunosuppression (leucocytes \\\u003C2 G\u002Fl)\n* peripheral arterial disease stage III-IV of the Fontaine Classification\n* fasting or other reasons preventing medication intake\n* previous enrolment into the current study\n* participation in another intervention study\n* pregnancy, breastfeeding, intention to become pregnant during the course of the study or lack of safe contraception.\n* end of life care",{"count":404,"type":21},172,[406],"PHASE4","Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients. It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP) secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP release and consecutive free water retention.\n\nCurrent treatments of euvolemic and hypervolemic hyponatremia, including the most used treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin (Jardiance)® in addition to fluid restriction was effective in increasing the serum sodium concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin (Jardiance)® without additional fluid restriction is however not yet known. Large randomized controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure in patients with, and more recently without type 2 diabetes. No studies have investigated the effect of SGLT2 inhibitors in hypervolemic hyponatremia.\n\nTo evaluate the effect of empagliflozin (Jardiance)® in eu- and hypervolemic hyponatremia, a randomized placebo-controlled study is needed.",[409,410,411,28],"Hyponatremia","SIADH","Liver Failure","2025-11-14",{"date":414,"type":38},"2025-11-17",{"date":416,"type":38},"2021-02-04",{"date":418,"type":21},"2027-02",{"name":420,"class":45},"University Hospital, Basel, Switzerland",6,{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":17,"minAge":430,"maxAge":144,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":439,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":4},"100605279","phase-4-levocarnitine-for-reducing-esa-requirements-in-hemodialysis-patients-with-renal-anemia-100605279","NCT07160452","Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia","Effect of Levocarnitine Injections on Reducing Erythropoietin-Stimulating Agent Requirements in Hemodialysis Patients With Renal Anemia","L-CAR-ESA","Inclusion Criteria:\n\n1. Both male and female patients\n2. Patients aged 20-60 years.\n3. Patients undergoing maintenance hemodialysis three times a week for at least six months\n4. Patients having renal anemia\n\nExclusion Criteria:\n\n1. Patients currently using any carnitine preparation as a supplement (to avoid confounding effects from additional carnitine intake).\n2. Patients on immunosuppressive drugs, steroids, or antibiotics (to avoid the influence of these medications on anemia and carnitine metabolism).\n3. Patients who have previously received levocarnitine in either oral or injected form (to eliminate any prior influence of levocarnitine on study outcomes).\n4. Patients with a history of blood transfusion within the past 6 months (to exclude the immediate impact of transfusions on hemoglobin levels and anemia management).\n5. Patients with acute inflammation (to prevent interference with study parameters as inflammation can affect anemia status).\n6. Patients with communication difficulties due to dementia or other factors (to ensure accurate symptom reporting and study adherence).","20 Years",{"count":432,"type":21},94,[406],"Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Carnitine deficiency is frequent in hemodialysis because carnitine is lost during dialysis and its synthesis is reduced. Levocarnitine may improve red blood cell function and reduce the dose of ESA needed to maintain hemoglobin.\n\nThis single-center, randomized controlled trial will test whether adding intravenous levocarnitine to standard care reduces ESA requirements in adults on maintenance hemodialysis who have renal anemia. Ninety-four participants (age 20-60 years) on thrice-weekly hemodialysis for ≥6 months and with hemoglobin \\\u003C10 g\u002FdL will be randomly assigned (1:1) to:\n\nIntervention: Levocarnitine 1,000 mg IV three times per week, administered after each dialysis session, plus usual anemia care including ESA per unit protocol.\n\nControl: Usual anemia care including ESA per unit protocol without levocarnitine.\n\nParticipants will be followed for 6 months. Hemoglobin, hematocrit, ESA dose, and the erythropoietin responsiveness index (ERI = monthly ESA dose ÷ \\[dry weight × average hemoglobin\\]) will be recorded monthly.\n\nThe primary outcome is the ESA dose (units\u002Fweek) at month 6. Secondary outcomes include ERI and monthly changes in hemoglobin and hematocrit, along with routine safety monitoring. If levocarnitine lowers ESA needs, the findings may offer a cost-effective strategy to optimize anemia management in hemodialysis patients.",[436,28,437,438],"Anemia","End-Stage Renal Disease","Renal Dialysis",[440,441,442,443,444],"Levocarnitine","L-carnitine","Erythropoiesis-Stimulating Agents","Erythropoietin Responsiveness Index","Hematocrit","2025-09-06",{"date":447,"type":38},"2025-09-12",{"date":449,"type":21},"2025-09-15",{"date":451,"type":21},"2026-03-15",{"name":453,"class":45},"Shaikh Zayed Hospital, Lahore",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":22,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":245},"100333874","phase-3-custodiol-n-solution-compared-with-custodiol-solution-in-organ-transplantation-kidney-liver-and-pancreas-100333874","NCT03627013","Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)","A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)","Inclusion Criteria:\n\n* All organs (kidney, combined kidney - pancreas and liver) Donor criteria\n\nFor All patients undergoing deceased donation:\n\n\\- deceased adult (≥18 years) donors fulfilling the criteria for organ donation\n\nFor All patients undergoing living kidney donation:\n\n\\- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation\n\nPatient (recipient) criteria\n\n* recipients awaiting their transplant\n* recipients ≥18 years\n* recipients' signed informed consent before the transplantation Kidney \u002F combined kidney - pancreas recipients\n* n\u002Fa Liver recipient\n* full organ transplantation\n\nExclusion Criteria:\n\n* All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)\n* \\- donors whose organs are all allocated out of retrieving study center\n* general refusal of organ donation\n* donation after cardiac death (DCD) Patient (recipient) criteria\n* pregnant or lactating patients\n* recipients participating in any interventional study (e.g. another study involving compound\u002Finterventions aimed at the reduction of preservation and \u002F or ischemia \u002F reperfusion injury)\n* all combined allocations other than pancreas and kidney\n\nKidney \u002F combined kidney -pancreas recipient\n\n* double kidney transplantation\n* pancreas retransplantation\n* machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA \\>0% are only included in the living donation setting.\n\nLiver recipient\n\n* retransplantation\n* machine perfusion",{"count":462,"type":21},362,[211],"Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)\n\nProtocol number: CL-N-KLP-TX-III\u002F07-AT\u002F17\n\nTrial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver.\n\nIntended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days).\n\nPurpose of the study\n\nThe objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas.\n\nPatient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study.\n\nPlanned number of patients (recipients)\n\nIn total N=362 including:\n\nKidney 242 (including approx. 30 combined kidney-pancreas)\n\nLiver 120",[28,466,467],"Liver Failure, Chronic","Kidney-Pancreas Failure","2025-09-03",{"date":470,"type":38},"2025-09-10",{"date":472,"type":38},"2019-05-23",{"date":474,"type":21},"2028-09-30",{"name":476,"class":370},"Dr. F. Köhler Chemie GmbH",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":489,"conditions":490,"keywords":493,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":77},"100582663","phase-2-use-of-new-drug-qrx-3-for-prevention-and-treatment-of-chronic-kidney-disease-progression-100582663","NCT06866236","Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression","Use of NAD Oxidase Modulation Agent QRX3 for Prevention and Treatment of Progressive Chronic Kidney Disease","NAD agent","Inclusion Criteria:\n\n* Inclusion criteria\n\n  * Patient with Chronic kidney disease\n  * Estimated Glomerular function by MDRD of less than 60mls\u002Fmin\n  * Patients with declining renal function ( as measured by eGFR by MDRD )\n  * Rate of decline of eGFR over the last one year of less than 20%\n  * Negative Serology markers for CKD etiology\n  * Provider perceived adherence to study follow up\n\nExclusion Criteria:\n\nRapid rate of decline in kidney function of \\> 20 % over last one year\n\n* Symptomatic renal failure\n* Presence of any suspected Acute renal failure superimposed\n* Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI\n* No known reversible cause of renal decline",{"count":486,"type":21},3000,[488,211],"PHASE2","Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study the investigators are using a novel drug to target improved function of the kidneys.",[491,492,28],"Chronic Kidney Diseases","Acute Kidney Injury",[494],"CKD, CKD treatment , renal function","2025-08-31",{"date":497,"type":38},"2025-09-08",{"date":499,"type":21},"2025-10",{"date":501,"type":21},"2027-07",{"name":503,"class":370},"Ebima Clifford Okundaye",{"id":505,"slug":506,"hasResults":11,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":511,"maxAge":512,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":523,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":77},"100597051","phase-1-crispr-edited-hla-donor-kidney-transplant-to-reduce-rejection-risk-100597051","NCT07053462","CRISPR-Edited HLA Donor Kidney Transplant to Reduce Rejection Risk","Phase 1\u002F2, Single-Arm, Open-Label Trial to Evaluate the Safety, Feasibility, and Immunogenicity of Ex Vivo CRISPR-Cas9 Gene-Edited Donor Kidneys (Knockout of HLA-A, HLA-B, and CIITA) in Human Renal Transplant Recipients","Inclusion Criteria:\n\n* Adult patients, age 16 to 85 years, with end-stage renal disease (ESRD) who are candidates for kidney transplantation. This includes patients on dialysis or approaching dialysis who have been evaluated and listed for transplant.\n* Eligible for transplant surgery based on medical assessment (i.e., no contraindications to major surgery and transplantation). The patient's overall health status must be sufficient to undergo the transplant procedure and the required immunosuppression.\n* Suitable donor organ available: A deceased-donor kidney that meets standard acceptable criteria for transplant (e.g., adequate organ function and anatomy) and is ABO blood type compatible with the recipient. The donor kidney must be allocated to the trial and available for ex vivo gene editing prior to transplantation.\n* Informed consent: The patient (or legally authorized representative) is able to understand the experimental nature of the study and has voluntarily signed the informed consent form. The patient must be willing to comply with all study procedures, follow-up visits, and laboratory tests.\n* Negative crossmatch (if applicable): No pre-existing anti-donor reactivity that would cause immediate graft failure. (All recipients should have a negative T and B cell crossmatch with the donor organ prior to transplant, as per standard practice, to ensure no strong baseline donor-specific antibodies, especially against any remaining donor HLA such as HLA-C.)\n* Women of childbearing potential must have a negative pregnancy test and must agree to use effective contraception during the study and for a period after (to be specified, e.g., 1 year post-transplant), given the use of immunosuppressants and the unknown effects of gene-edited organ transplantation on pregnancy. Men with partners of childbearing potential should also agree to use contraception.\n* High immunologic risk patients are eligible: Patients with high panel reactive antibody (PRA) levels or a history of sensitization (from prior transplants, blood transfusions, or pregnancies) are allowed and even anticipated in this trial, as the intervention is designed to benefit patients with broad HLA sensitization. For instance, patients with calculated PRA \\> 80% (who have difficulty finding matched donors) can be included. (Such patients must still meet the crossmatch criterion above - any existing antibodies should not target the antigens remaining on the edited graft.)\n* Geographic availability: Patients must be available for long-term follow-up in the study center in China or able to travel for scheduled follow-up visits. They should be willing to remain in proximity to the transplant center for the initial post-operative period as per standard transplant care.\n\nExclusion Criteria:\n\n* Active infection: Any ongoing severe infection that would contraindicate transplantation or be exacerbated by immunosuppression (e.g., active tuberculosis, untreated Hepatitis B or C, HIV with uncontrolled viremia, etc.). Patients with controlled HIV (on stable antiretroviral therapy with undetectable viral load) may be considered on a case-by-case basis, but active uncontrolled infection is excluded.\n* Pregnancy or breastfeeding: Pregnant women are excluded due to the need for immunosuppressive drugs and the unknown risks of the investigational intervention on a fetus. Women who are breastfeeding are also excluded due to potential drug excretion in milk and unknown risks to the infant.\n* Multi-organ transplant need: Patients requiring more than one organ transplant simultaneously (e.g., kidney + liver, or kidney + heart) are excluded, as this trial focuses on isolated kidney transplant outcomes. (A history of a prior transplant is not an automatic exclusion if the patient now only needs a kidney, but concurrent multi-organ requirements are excluded.)\n* Severe co-morbidities that would significantly increase transplant risk or confound results: for example, uncontrolled cardiovascular disease (e.g., recent myocardial infarction, severe heart failure), uncontrolled diabetes with end-organ damage beyond ESRD, severe liver dysfunction, or other life-threatening illnesses unrelated to kidney failure. Such conditions could make the surgery unsafe or the outcome hard to interpret.\n* Contraindications to immunosuppression: Patients with conditions that preclude standard immunosuppressive therapy (for instance, a history of anaphylaxis to tacrolimus or mycophenolate that cannot be managed, or chronic infection that would be fatally worsened by immunosuppression) are excluded. The trial still relies on baseline immunosuppressants, so patients must be able to tolerate them.\n* Inability to follow the protocol: Patients with significant psychiatric disorders, cognitive impairment, or social situations that would make adherence to the study protocol and follow-up unlikely. This includes inability to give informed consent or lack of support for the intensive follow-up (for example, if the patient is incarcerated or has no fixed address, etc.).\n* Prior gene therapy or organ experiment participation: Patients who have previously received any investigational gene therapy, or who have a donor-specific tolerance induction or other experimental transplant treatments ongoing, may be excluded to avoid confounding effects. (This is a precaution to attribute outcomes specifically to the CRISPR-edited organ intervention.)\n* Laboratory abnormalities: Any clinically significant abnormalities in baseline labs that would pose added risk - for instance, severe leukopenia or thrombocytopenia that could worsen with immunosuppression, or uncontrolled coagulopathy that raises surgical risk.\n* Donor-related exclusions: If the donor kidney, upon retrieval, is found unsuitable for gene editing or transplant (e.g., poor organ quality, unexpected disease in the organ, or if the CRISPR editing fails to achieve sufficient knockout of target genes), the transplant to that patient will not proceed under the study (the patient may either receive a standard transplant off-study or wait for another opportunity). In such a case, the patient might be withdrawn or deferred, but this is a procedural consideration rather than a characteristic of the patient.","16 Years","85 Years",{"count":514,"type":21},90,[88,488],"This clinical trial investigates the transplantation of donor kidneys that have been genetically modified ex vivo using CRISPR-Cas9 genome editing to reduce immunogenicity and transplant rejection. Donor kidney grafts will have key human leukocyte antigen (HLA) genes disrupted - specifically, knockout of HLA class I heavy chains HLA-A and HLA-B, along with disabling HLA class II expression by targeting the CIITA gene (a master regulator of HLA-DR\u002FDQ\u002FDP). Approximately 90 adult end-stage renal disease patients will receive a CRISPR-edited donor kidney transplant. The primary objectives are to assess the safety and feasibility of this novel intervention, while secondary objectives evaluate the reduction in immune responses (immunogenicity), graft function, and the practicality of implementing ex vivo gene-edited organ transplantation in humans. By knocking out major donor HLA molecules, the trial aims to reduce T-cell and antibody-mediated recognition of the graft, potentially lowering rejection rates and reliance on high-dose immunosuppressants. Safety, including any off-target effects or unanticipated immune reactions, will be closely monitored, and transplant outcomes will be tracked for one year post-transplant.",[437,518,519,520,521,28,522],"End Stage Renal Disease on Dialysis","End Stage Renal Disease With Renal Transplant","Kidney Transplant Rejection","Kidney Tumor","Kidney Ischemia",[524,525,526,28,527,91,528,529,530],"HLA Mismatch Immunogenicity","Transplant Rejection (Immunologic)","Kidney Transplantation (Allograft)","CRISPR-Cas9","Human Leukocyte Antigen (HLA)","Immunogenicity Reduction","Graft Rejection Prevention","2025-06-26",{"date":533,"type":38},"2025-07-08",{"date":535,"type":38},"2025-06-01",{"date":537,"type":21},"2028-12-28",{"name":539,"class":45},"AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC",{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":256,"phases":4,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":77},"100566796","amino-acid-loss-during-continuous-renal-replacement-therapy-100566796","NCT06659835","Amino Acid Loss During Continuous Renal Replacement Therapy","Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study","DIAMINO","Inclusion criteria:\n\n* Postoperative ICU patients\n* Age ≥ 18 years\n* Patients on enteral or\u002Fand parenteral nutrition given according to internal standard operating procedure\n\nA) CRRT group:\n\n\\- CRRT treatment planned; all types of CRRT (continuous veno-venous hemodialysis (CVVHD), continuous veno-venous hemodiafiltration (CVVHDF), continuous veno-venous hemofiltration (CVVH))\n\nB)Non-CRRT group:\n\n* no current or previous (\\\u003C30 days) continuous or intermittent RRT\n* no chronic kidney disease stage G3-G5\n\nExclusion criteria:\n\n* Preoperative intensive care patients\n* Patients with liver cirrhosis stage 1-3 according to the Child-Pugh classification\n* Patients with acute liver failure",{"count":549,"type":21},30,"The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are:\n\nWhat amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy?\n\nAmino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.",[552,28],"Renal Insufficiency",[554,555,556],"amino acid","continuous renal replacement therapy","effluent loss","2025-05-21",{"date":559,"type":38},"2025-05-25",{"date":561,"type":38},"2025-02-08",{"date":563,"type":21},"2026-12",{"name":565,"class":45},"Medical University of Vienna",{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":575,"briefSummary":576,"conditions":577,"keywords":580,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":77},"100584485","phase-2-the-effect-of-daratumumab-in-patients-with-monoclonal-gammopathy-of-renal-significance-mgrs-in-finland-100584485","NCT06889948","The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland","Daratumumab in Monoclonal Gammopathy of Renal Significance in Finland","DAMOCLES","Inclusion Criteria:\n\n1. Males or females ≥ 18 years of age\n2. Subject has provided informed consent prior to initiation of the study or subject's legally acceptable representative has provided informed consent prior to the study when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.\n3. Renal biopsy confirmed MGRS-disease\n\n   * Renal biopsy must not be older than 3 months before informed consent. However, if renal biopsy is older than 3 mo and the study team is convinced that major histological changes have not occurred, a biopsy older than that can exceptionally be accepted.\n   * Renal transplant patients are allowed\n4. Amount of proteinuria ≥ 500 mg\u002F24 h OR eGFR ≥ 20 ml\u002Fmin prior to the study\n5. Previous anticlonal treatment is allowed if deemed ineffective\n\nExclusion Criteria:\n\n1. Myeloma or systemic AL amyloidosis (smoldering myeloma sized plasma cell clone is allowed when in association with a documented MGRS condition and AHL amyloidosis and AH amyloidosis are included)\n2. Cancer that requires treatment,\n3. MGRS related to B-cell malignant disorders,\n4. Known HIV infection, active hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response (PCR negativity in HBVNh) with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study),\n5. Pregnancy or breastfeeding,\n6. Cyclophosphamide within 6 months of enrollment, or oral high-dose prednisone or equivalent within 6 weeks of enrollment;\n\n   * prednisone or its equivalent at a dosage of ≤10 mg daily for a condition unrelated to MGRS (e.g. asthma or gout) allowed.\n   * mycophenolate mofetil (MMF), calcineurin inhibitors (CNI) or azathioprine treated patients are eligible if proteinuria is not improving or if kidney function is declining despite treatment with these medications. Once therapy with daratumumab started, these medications need to be discontinued unless they are used as immunosuppressive medication due to renal transplantation.\n7. In patients who previously received rituximab, reconstitution of B cells (CD19 normalized, Ly-B-CD19 lab.code 8329) required.\n8. Inability to use daratumumab and to comply with the study protocol as assessed by treating nephrologist and\u002For hematologist (e.g. severe psychiatric illness, severe lung disease, known allergy to daratumumab)",{"count":549,"type":21},[488],"The goal of this clinical trial is to learn if drug daratumumab works to treat kidney diseases other than AL-amyloidosis that fall under the category of monoclonal gammopathy of renal significance (MGRS).\n\nThe main questions it aims to answer are:\n\nDoes daratumumab have an effect on the patients' renal function or the amount of proteinuria?\n\nDoes daratumumab have an effect on the hematological endpoints evaluated by minimal residual disease (MRD) and the difference between involved and uninvolved free light chain (dFLC)?\n\nAlso changes in quality of life (according to EORTC QLQ-C30) and mechanism of complement system activation are evaluated. The number of patiets with partial or very good partial hematological remission and the number of patients with adverse events related to daratumumab are also recorded.",[28,578,579],"Paraproteinemias","Glomerulonephritis",[581,582],"Monoclonal gammopathy of renal significance","daratumumab","2025-03-17",{"date":585,"type":38},"2025-03-21",{"date":587,"type":38},"2024-01-19",{"date":589,"type":21},"2027-06",{"name":591,"class":45},"Helsinki University Central Hospital",{"id":593,"slug":594,"hasResults":11,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":599,"targetDuration":4,"studyType":22,"phases":601,"briefSummary":602,"conditions":603,"keywords":607,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":77},"100542059","deceased-donor-bladder-or-combined-kidney-bladder-transplantation-a-phase-0-first-in-human-study-100542059","NCT06337942","Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study","Vascularized Composite Bladder Allograft Transplantation: a Phase 0 (First-in-human) Study for Deceased Donor Bladder or Combined Kidney-bladder Transplantation","Inclusion Criteria:\n\n* Age 18-70 years\n* Positive history of one of the following:\n\n  1. Terminal bladder pathology resulting in poor compliance, recurrent refractory infections, and\u002For and resultant upper tract (kidney and ureteral) pathology, with possible resultant kidney disease.\n  2. Localized, non-metastatic, bladder cancer requiring radical cystectomy. In this protocol, the only patients with a history of urothelial cell carcinoma that has already been treated, with an appropriate disease-free interval would be considered. Moreover, only candidates requiring a joint kidney and bladder transplantation or patients with a pre-existing transplant, on standard immunosuppression, will be considered.\n* Patients that are on immunosuppression for pre-existing solid organ transplantation will be included in this study.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.\n* Patient has been previously fully vaccinated and boosted against COVID-19, or is willing to undergo timely vaccination.\n\n  (a) Caretakers of the recipient will be strongly encouraged to be vaccinated.\n* Patients must demonstrate appropriate manual dexterity or sufficient assistance at home to perform clean intermittent catheterizations as needed. The patient (or assistant) must demonstrate proficiency in performing clean intermittent catheterization during pre-transplant workup.\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of genitourinary transplantation. Examples of such medical conditions would include burden of atherosclerotic disease that would preclude vascular anastomosis, and psychiatric disorders that would preclude reliable adherence to medications.\n* No active co-existing psychosocial problems (i.e., alcoholism, drug abuse).\n* Negative crossmatch with donor.\n\nExclusion Criteria:\n\n* Positive history of one of the following medical co-morbidities:\n\n  1. HIV (active or seropositive), active hepatitis B or C, viral encephalitis, untreated sepsis, active tuberculosis, viral encephalitis, toxoplasmosis, varicella zoster virus\n  2. Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like hemophilia, Von-Willebrand's disease, protein C and S deficiency, thrombocythemia, thalassemia, sickle cell disease.\n  3. Mixed connective tissue diseases and collagen disorders (can result in poor wound healing after surgery), including: mixed connective tissue disorder; severe deforming rheumatoid arthritis; infectious, post-infectious, or inflammatory (axonal or demyelinating) neuropathy; Ehlers-Danlos syndrome;\n  4. lipopolysaccharidosis or amyloidosis (effects nerve regeneration)\n  5. Impaired liver function as evaluated by liver function panel, including the presence of hyperbilirubinemia, elevated AST\u002FALT, and the presence of secondary coagulopathy, measured by prothrombin, international normalized ratio, and partial thromboplastin time.\n  6. Severe anemia (hemoglobin \\\u003C 7 g\u002FdL), leukopenia (WBC \\\u003C 3 x 109 cell\u002FL), or thrombocytopenia (platelets \\\u003C 20 x109 cells\u002FL).\n* Patient is either not vaccinated or is unwilling to undergo vaccination against COVID-19 prior to transplantation.\n* Oncology patient specific:\n\n  1. History of non-urothelial malignancy in past 5 years, with the exception of non-melanomatous skin cancer\n  2. History of malignancy involving metastases\n* Patients unable to receive adequate follow-up care and\u002For unable to receive immunosuppression due to geographic, financial or other reasons.\n* Patients with a smoking history who cannot demonstrate smoking cessation for a period of 6 months prior to listing and a desire to abstain from post-operative smoking will be excluded.\n* Records of poor medical compliance, documented psychological disorder(s), substance abuse or incomplete psychological clearance.\n* Particular attention will be paid to the candidate's compliance and their desire to undergo the offered procedure. While there is no \"score\" on any particular evaluation that would rule out a patient, certain factors can aid in the identification of patients who for example may not have the ability to comply with the medical directives necessary to care for a genitourinary transplant, or psychologically are not prepared for transplant, or who have unrealistic expectations about the transplant. The decision on eligibility is a team decision. All members of the team will discuss each candidate in a multidisciplinary meeting and reasons for concern over eligibility will be discussed at a Selection Committee Meeting. In circumstances where the candidate is considered to be less suitable, they could be given an opportunity to address these issues either through individual counseling or further education and then be reconsidered as a potential candidate. Every effort to prevent a request for allograft removal will be made.",{"count":600,"type":21},5,[24],"The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are:\n\n* Is human bladder transplantation feasible and safe?\n* How will the new bladder function in terms of storage and emptying?\n\nParticipants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant.",[604,605,606,28],"Bladder Disease","Bladder, Neurogenic","Bladder Cancer",[608,609,610,611],"terminal bladder","vascularized composite bladder allograft","bladder transplantation","combined kidney and bladder transplantation","2025-02-10",{"date":614,"type":38},"2025-02-12",{"date":616,"type":38},"2025-02-01",{"date":618,"type":21},"2028-01",{"name":620,"class":45},"University of California, Los Angeles",{"id":622,"slug":623,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":11,"sex":17,"minAge":628,"maxAge":352,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":643,"locationsCount":199},"100522395","phase-3-multifactorial-intervention-to-reduce-cardiovascular-disease-in-type-1-diabetes-100522395","NCT06082063","Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes","Steno1","Inclusion Criteria:\n\n1. Given written informed consent\n2. Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)) during \\>10 years.\n3. Presence of chronic kidney disease (UACR \\>30 mg\u002Fg or eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI\\>35 kg\u002Fm2) OR 10-year CVD risk \\>10% according to Steno Type 1 Risk Engine.\n4. Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG.\n5. Ability to communicate with the investigator and understand informed consent.\n\nExclusion Criteria:\n\n1. Type 2 diabetes, MODY, secondary diabetes.\n2. History of pancreatitis.\n3. Body mass index \\\u003C 18.5 kg\u002Fm2\n4. Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods.\n5. Known or suspected abuse of alcohol or recreational drugs.\n6. Participant in another intervention study.\n7. CKD stage 5.","40 Years",{"count":630,"type":21},2000,[211],"A prospective, randomised, open-labelled, multi-center study. The aim of the Steno 1 study is to test multifactorial intervention in individuals with type 1 diabetes at high risk of CVD with ambitious treatment targets. We will include 2000 participants. Follow-up is 5 years.",[634,635,636,28],"Cardiovascular Diseases","Heart Failure","Type 1 Diabetes","2025-01-08",{"date":639,"type":38},"2025-01-10",{"date":641,"type":38},"2024-07-01",{"date":367,"type":21},{"name":644,"class":45},"Steno Diabetes Center Copenhagen",{"id":646,"slug":647,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":22,"phases":654,"briefSummary":655,"conditions":656,"keywords":658,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":660,"lastUpdatePostDateStruct":661,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":199},"100571742","preventing-delayed-graft-function-in-kidney-transplant-patients-100571742","NCT06724211","Preventing Delayed Graft Function in Kidney Transplant Patients","Preventing Delayed Graft Function in Kidney Transplant Patients: A Single-centre, Randomised, Feasibility Trial","PDF","Inclusion Criteria:\n\n* ≥ 18 years\n* Patients undergoing kidney transplantation\n* Living and deceased donor recipients\n\nExclusion Criteria:\n\n* Multi-organ transplant\n* Pre-emptive KT\n* Arterial line not planned for surgery",{"count":294,"type":21},[24],"The health and quality of life benefits of kidney transplantation are reduced by delayed graft function (DGF). There are a number of modifiable risk factors associated with DGF, such as intraoperative hypotension, the type of intravenous fluid used, glycemic control, and the restriction of blood transfusions. However, these factors have been assessed individually, and their collective effect on reducing the risk of DGF requires further investigation. We first propose a pilot RCT to establish the feasibility of a definitive RCT examining the impact of a treatment bundle of care on DGF.\n\nThis will be a single centre, double-blinded pilot RCT including 50 adults undergoing kidney transplantation. Patients will be randomized to either the experimental group, which will consist of a treatment bundle of care, or to the control group, which will consist of routine clinical care for kidney transplant patients. The treatment bundle of care will consist of: the use of plasmalyte for fluid management, maintaining mean arterial pressure \\> 75 mmHg, identify and treat blood glucose \\> 9 mmol\u002FL, and a restrictive criteria for red blood cell transfusions (i.e. hemoglobin (Hb) \\\u003C 70 g\u002FL).\n\nThe primary outcome of this pilot study is the recruitment rate. Recruitment rate will be defined as the number of patients who are approached to participate in the study and who are randomized to either the experimental or control group, as a percentage of the total number of eligible kidney transplant patients. The secondary outcomes are: 1) protocol adherence rate and 2) follow-up rate. Protocol success will be defined as a ≥90% compliance with at least 3 of the 4 treatment bundle components. Patient follow-up will end at 90-days after transplant and the target is to follow ≥90% of the patients until this time. DGF and acute rejection will not be assessed in the feasibility trial, and instead this data will be analyzed in the full trial.",[91,28,657],"Kidney Injury",[91,659],"Surgical Bundle","2024-12-05",{"date":662,"type":38},"2024-12-09",{"date":664,"type":21},"2025-01-15",{"date":666,"type":21},"2026-04",{"name":668,"class":45},"University Health Network, Toronto",{"id":670,"slug":671,"hasResults":11,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":207,"enrollmentInfo":677,"targetDuration":4,"studyType":22,"phases":679,"briefSummary":680,"conditions":681,"keywords":683,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":686,"lastUpdatePostDateStruct":687,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":4},"100559868","effects-of-homemade-oral-nutrition-supplements-for-patients-on-hemodialysis-with-protein-energy-wasting-100559868","NCT06569732","Effects of Homemade Oral Nutrition Supplements for Patients on Hemodialysis With Protein-energy Wasting","Clinical Efficacy, Feasibility, and Cost-effectiveness of Homemade Oral Nutrition Supplements on Patients on Hemodialysis With Protein-energy Wasting: a Parallel, Open-labeled, Randomized Controlled Trial","HOMES-HD","Inclusion Criteria:\n\n* on maintenance HD dialysis treatment (thrice weekly and 4-hour per session) for at least three months\n* age 18 - 70 year old\n* diagnosed with protein energy wasting using the malnutrition inflammation score (≥ 5)\n\nExclusion Criteria:\n\n* a history of poor adherence to HD treatment (frequently miss the HD treatment for more than one session every month)\n* a history of frequent hospitalization (more than once in the past one month)\n* on regular oral nutrition supplements\n* diagnosed with malignancy\n* pregnant or lactating women\n* allergic to study products such as soy milk or milk",{"count":678,"type":21},40,[24],"The goal of this clinical trial is to learn if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis. It will also learn about the cost-effectiveness of homemade oral nutrition supplements. The main questions it aims to answer are:\n\n* Does homemade oral nutrition supplements improve the nutritional status of patients on hemodialysis with protein energy wasting?\n* What is the cost-effectiveness of homemade oral nutrition supplements?\n\nResearchers will compare homemade oral nutrition supplements to commercial oral nutrition supplements to see if homemade oral nutrition supplements works to treat protein energy wasting in patients on hemodialysis.\n\nParticipants will:\n\n* Take homemade or commercial oral nutrition supplements every day for 6 months\n* Have assessment of nutritional status performed by researchers every three monthly",[682,28,360],"Protein-Energy Wasting",[684,685,268],"hemodialysis","protein-energy wasting","2024-08-23",{"date":688,"type":38},"2024-08-26",{"date":690,"type":21},"2024-11",{"date":692,"type":21},"2025-11",{"name":694,"class":45},"Universiti Malaysia Sabah",{"id":696,"slug":697,"hasResults":11,"nctId":698,"briefTitle":699,"officialTitle":700,"acronym":4,"eligibilityCriteria":701,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":702,"targetDuration":4,"studyType":256,"phases":4,"briefSummary":704,"conditions":705,"keywords":4,"overallStatus":308,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":711,"leadSponsor":713,"locationsCount":77},"100543126","predicting-adverse-kidney-events-of-cardiac-surgery-associated-acute-kidney-injury-using-novel-biomarkers-100543126","NCT06351813","Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers","Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers--A Multicenter Observational Study","Inclusion Criteria:\n\n* Patients undergoing cardiac surgery who experienced AKI within 48 hours of cardiac surgery were screened.\n\nExclusion Criteria:\n\n* History of End Stage Renal Disease or on Dialysis;\n* prior kidney transplantation;\n* patients with a DNR order;\n* patients without written informed consent;\n* pregnancy;\n* moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)",{"count":703,"type":21},358,"The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes.",[492,706,28],"Critical Illness","2024-06-07",{"date":709,"type":38},"2024-06-10",{"date":641,"type":21},{"date":712,"type":21},"2027-12-31",{"name":714,"class":45},"Shanghai Zhongshan Hospital",{"id":716,"slug":717,"hasResults":11,"nctId":718,"briefTitle":719,"officialTitle":720,"acronym":4,"eligibilityCriteria":721,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":722,"targetDuration":4,"studyType":256,"phases":4,"briefSummary":724,"conditions":725,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":726,"lastUpdatePostDateStruct":727,"startDateStruct":729,"completionDateStruct":731,"leadSponsor":733,"locationsCount":77},"100158196","biobank-renal-transplantation-university-hospitals-leuven-100158196","NCT01331668","BIOBANK Renal Transplantation University Hospitals Leuven","Biobank Renal Transplantation University Hospitals Leuven","Inclusion Criteria:\n\n* renal transplant recipients\u002Fdonors\n\nExclusion Criteria:\n\n* none",{"count":723,"type":21},5000,"This study aims to maintain a prospective biobank of human samples obtained from donors and recipients of renal allografts, including biopsy tissue, peripheral blood samples and urine samples.",[28],"2024-05-06",{"date":728,"type":38},"2024-05-08",{"date":730,"type":4},"2004-03",{"date":732,"type":21},"2099-12",{"name":734,"class":45},"Universitaire Ziekenhuizen KU Leuven"]