[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-failure-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-failure-chronic":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,51,94,123,156,186,232,265,294,319,354,390,423,450,480,509,534,557,583,612],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100643721","evolution-of-physical-frailty-and-patient-reported-outcome-measures-in-kidney-transplant-candidates-a-mixed-methods-longitudinal-study-protocol-100643721",false,"NCT07607041","Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol","Longitudinal Tracking of Physical Frailty and Health-Related Quality of Life Through Patient-Reported Outcome Measures in Adult Candidates on the Kidney Transplant Waiting List","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Diagnosed with Stage 5 chronic kidney disease (CKD).\n* Currently undergoing clinical evaluation for or actively listed on the deceased-donor kidney transplant waiting list at Hospital del Mar (Barcelona).\n* Cognitive and physical ability to understand and provide written informed consent.\n* Ability to use or have regular access to a digital device (smartphone or tablet) for electronic Patient-Reported Outcome Measures (ePROMs) completion.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or active psychiatric disorders that prevent the reliable completion of questionnaires or physical tests.\n* Major physical disability that precludes the objective assessment of gait speed or handgrip strength (e.g., bilateral lower limb amputation or severe dominant hand deformity).\n* Acute medical illness requiring hospitalization at the time of enrolment.\n* Total language barrier that prevents understanding the study components or the qualitative interview.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","24 Months","OBSERVATIONAL","This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become \"frail.\" This means they lose strength and are at a higher risk for health problems.\n\nThe main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology.\n\nThe results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use.\n\nIn short, this work aims to help patients reach the day of their surgery in the best possible condition.",[25,26,27,28,29],"Kidney Failure, Chronic","Frailty","Quality of Life","Kidney Transplantation","Patient Reported Outcome Measures",[28,31,32,33,34,35,36,37,38],"Waiting Lists","Health-Related Quality of Life","Digital Health","Longitudinal Studies","Mixed Methods Research","Hermeneutics","Patient-Centered Care","Technology Assessment, Biomedical","NOT_YET_RECRUITING","2026-06-05",{"date":42,"type":43},"2026-06-08","ACTUAL",{"date":45,"type":20},"2026-07",{"date":47,"type":20},"2028-07",{"name":49,"class":50},"Hospital del Mar","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100640982","phase-1-immunological-reset-to-enable-access-to-hla-compatible-kidney-transplantation-in-highly-sensitized-patients-reset-100640982","NCT07607197","Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)","Immune Reset to Allow Access to Hla-compatible Kidney Transplantation in Hyperimmunized Patients","HIPER-RESET","Inclusion Criteria:\n\n* Patients aged between 18 and 60 years.\n* Diagnosis of end-stage kidney disease (ESRD) currently maintained on chronic dialysis.\n* Highly sensitized\u002Fhyperimmunized status, defined by a high calculated Panel Reactive Antibody (cPRA) level (e.g., \\>= 95%).\n* Active status on the deceased-donor kidney transplant waiting list.\n* Adequate bone marrow, hepatic, cardiac, and pulmonary function to safely undergo the conditioning regimen and AHSCT.\n* Capable of understanding the study requirements and providing written informed consent.\n\nExclusion Criteria:\n\n* Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG).\n* Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis).\n* Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \\\u003C 50%) or severe underlying pulmonary disease.\n* History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ.\n* Previous autologous or allogeneic hematopoietic stem cell transplantation.\n* Pregnancy or breastfeeding.\n* Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.","60 Years",{"count":61,"type":20},10,"INTERVENTIONAL",[64,65],"PHASE1","PHASE2","The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant.\n\nPatients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely.\n\nThis study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch.\n\nThe investigators hypothesize that this procedure will eliminate the \"immunological memory\" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a \"naive\" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.",[25,28,68,69,70,71],"Alloimmunization","HLA Sensitization","End Stage Cronic Kidney Disease","Highly Sensitized Patients Awaiting Kidney Transplant",[73,74,28,75,76,77,78,79,80,81,82],"Autologous Hematopoietic Stem Cell Transplantation","AHSCT","Highly sensitized","Hyperimmunized","Desensitization","Anti-HLA Antibodies","CD34+ Cells","Transplant Immunology","End-Stage Kidney Disease","Immune Reset","RECRUITING","2026-06-02",{"date":86,"type":43},"2026-06-04",{"date":88,"type":43},"2024-02-01",{"date":90,"type":20},"2028-06",{"name":92,"class":50},"Hospital Universitari Vall d'Hebron Research Institute",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":62,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":93},"100549776","effects-of-royal-jelly-supplementation-in-chronic-kidney-disease-100549776","NCT06438445","Effects of Royal Jelly Supplementation in Chronic Kidney Disease","Effects of Royal Jelly Supplementation on Inflammation and Cellular Senescence in Chronic Kidney Disease Patients Under Hemodialysis","Inclusion Criteria:\n\n* patients with CKD undergoing hemodialysis for more than 6 months\n* patients with arteriovenous fistula (AVF) as vascular access.\n\nExclusion Criteria:\n\n* pregnant,\n* lactating,\n* smoker\n* patients using antibiotics and antioxidant supplements in the last three months\n* patients with autoimmune and infectious diseases,\n* patients with cancer, liver disease, and AIDS","70 Years",{"count":103,"type":20},30,[105],"NA","The objective of this study is to evaluate the effects of royal jelly on inflammation and cellular senescence in patients with chronic kidney disease (CKD) on hemodialysis (HD).",[25,108,109],"Oxidative Stress","Hemodialysis",[111,112,113,108],"Cellular Senescence","Renal Dialysis","Renal Insufficiency, Chronic","2026-05-14",{"date":116,"type":43},"2026-05-18",{"date":118,"type":43},"2024-07-30",{"date":120,"type":20},"2027-04-05",{"name":122,"class":50},"Universidade Federal Fluminense",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":16,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":134,"studyType":22,"phases":4,"briefSummary":135,"conditions":136,"keywords":140,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100201063","international-pediatric-peritoneal-biobank-100201063","NCT01893710","International (Pediatric) Peritoneal Biobank","Inclusion Criteria\n\n* Age 0 to 90 years\n* CKD 5D, peritoneal dialysis and\n* Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)\n* Patients post PD and post Tx\n* Oral and written consent\n* Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively\n\nExclusion Criteria:\n\n* Abdominal adhesions, malformation and inflammation beyond PD induced changes\n* Patients with disseminated tumour disease\n* Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk\n* Pregnancy\n* Preterm babies (below 37 weeks of gestational age)\n* Serum hemoglobin \\\u003C 10 g\u002Fdl in newborns and \\\u003C 8 g\u002Fdl in children and adults",true,"1 Day","90 Years",{"count":133,"type":20},500,"2 Years","Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.\n\nAn international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.\n\n3\u002F2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.",[25,137,138,139],"Peritoneal Dialysis Complication","Transplantation","Healthy",[141,142,143,144,145],"peritoneal dialysis","parietal peritoneum","omentum","chronic kidney disease","vasculopathy","2026-04-29",{"date":148,"type":43},"2026-04-30",{"date":150,"type":43},"2011-02-01",{"date":152,"type":20},"2028-12-31",{"name":154,"class":50},"Heidelberg University",26,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":62,"phases":167,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":184,"locationsCount":93},"100634831","pea-fibre-in-hemodialysis-100634831","NCT07544797","Pea Fibre in Hemodialysis","Influencing Microbiota and Uremic Toxins With Pea Fibre Intervention in Nephrology","MUFIN","Inclusion Criteria:\n\n* male and female patients 18-89 years of age\n* chronic hemodialysis treatment minimum 3 months for any kind of kidney disease\n* 2-3 hemodialysis sessions per week\n* expected to continue regular treatment for at least 3 months\n* written informed consent\n\nExclusion Criteria:\n\n* Persons younger than 18 or older than 89 years\n* Clinically relevant infections at the time of the study or within 2 weeks prior to study inclusion\n* Use of immunosuppressive medications, with the exception of glucocorticoids ≤ 5 mg prednisolone equivalent\n* Liver cirrhosis, Child-Pugh stage C\n* Active malignancy, with or without specific oncological therapy\n* Blood transfusion within 4 weeks prior to inclusion, or severe anemia with a current indication for blood transfusion\n* Planned absence (e.g., vacation) for more than 1 week during the study period\n* Pregnancy\n* Intolerance to gluten, eggs, milk, yeast, nuts, or pea protein\n* Missing consent to participate in the study\n* Inability to understand the study content and procedures and to provide informed consent after appropriate explanation\n* Persons institutionalized by court or administrative order\n* Simultaneous participation in another interventional study","89 Years",{"count":166,"type":20},72,[105],"Background and problem Chronic kidney disease (CKD) affects a large share of adults worldwide and is a growing public-health concern. People with advanced CKD can develop \"uremia\", a dangerous build-up of waste products in the blood that the failing kidneys cannot remove. Even when patients receive regular dialysis, many so-called \"uremic toxins\" remain in the body because some of these substances bind tightly to blood proteins and are poorly removed by dialysis. Over 100 uremic toxins have been identified and classified and protein-bound toxins such as Indoxylsulfate and p-Cresylsulfate are especially difficult to clear by dialysis.\n\nSome uremic toxins are linked to heart and blood-vessel disease, inflammation, and worse outcomes in dialysis patients. For example, Indoxylsulfate has been associated with higher mortality, vascular calcification, vessel stiffness and heart failure. Reducing these toxins might therefore improve quality of life and lower cardiovascular risk in people on dialysis.\n\nPurpose of the study The study will test whether adding inner, fermentable pea fiber (a natural prebiotic) to the daily diet of hemodialysis patients can lower blood levels of uremic toxins-especially Indoxylsulfate-and improve related markers of inflammation and cardiovascular risk. The investigators hypothesize that fermentable fibers change gut bacterial composition so that less toxin-forming bacterial metabolism (from amino acids like tryptophan) occurs, thereby reducing the amount of harmful metabolites that reach the blood.\n\nType of study: Randomized, double-blind, controlled trial with two groups. Duration: 8 weeks of intervention. Intervention: Participants will receive daily baked goods (bread, rolls, muffins, scones, pizza bread) that together provide 20 g of pea fiber per day; the control group will receive identical foods without added pea fiber. The fiber mix uses commercially available inner pea-fiber products.\n\nBlood and stool sampling: Blood samples are taken before the intervention, at 4 weeks and at 8 weeks to measure Indoxylsulfate and other toxins, inflammation markers, vitamin D metabolites and cardiovascular risk markers. A subgroup will also provide stool samples to study changes in the gut microbiome.\n\nWho can join Adults aged 18-89 who have been on chronic hemodialysis for at least three months and receive dialysis two to three times per week are eligible. The study excludes people with recent serious infections, advanced liver disease, active cancer, recent blood transfusion, pregnancy, certain food intolerances or inability to consent. Each study arm will include 36 participants.\n\nPrimary and secondary outcomes Primary outcome: Change in blood Indoxylsulfate concentration between the pea-fiber group and the control group.\n\nSecondary outcomes: Levels of other uremic toxins, routine kidney-related blood tests (creatinine, urea, uric acid), electrolytes, vitamin D metabolites, inflammatory markers, lipid markers, FGF23, short-chain fatty acids, sKlotho, and the effect of patient serum on cytokine production in a standard immune cell line. Stool analyses in a subgroup will examine shifts in bacterial groups and metabolic networks.\n\nHow the intervention is delivered and monitored Foods are prepared in a certified bakery and coded so neither participants nor study staff know who receives pea fiber or placebo. To improve adherence, participants choose from a variety of pre-portioned baked items and are advised to spread intake across the day. Unused portions are returned and logged. Dietary recalls and symptom questionnaires are collected to monitor changes in overall diet, appetite and gastrointestinal side effects. Blood draws are timed before dialysis after the long interdialytic interval to standardize measurements.\n\nPotential impact and limitations If fermentable inner pea fibers lower Indoxylsulfate and related toxins, this would support a simple, food-based strategy to reduce toxin burden and possibly cardiovascular risk in dialysis patients. However, previous studies show mixed results depending on the type of fiber used: fermentable fibers (like amylose-rich starch or inulin) have produced beneficial changes in some trials, while non-fermentable fibers did not. Since evidence high-quality randomized trials in dialysis patients is still limited there is the need for this study.",[109,170],"Kidney Failure Chronic",[172,173,174,175,176,177],"prebiotics","hemodialysis","pea fibre","indoxylsulfate","kidney failure chronic","uremic toxin","2026-04-15",{"date":180,"type":43},"2026-04-22",{"date":182,"type":20},"2026-05-01",{"date":152,"type":20},{"name":185,"class":50},"Martin-Luther-Universität Halle-Wittenberg",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":193,"targetDuration":4,"studyType":62,"phases":195,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"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",{"count":194,"type":20},132,[196],"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.",[199,200,25,28,201],"Kidney Transplant Recipient Response to Shingrix Vaccine","Kidney Failure","Herpes Zoster (HZ)",[203,204,205,206,207,200,208,209,210,211,212,213,214,215,216,217,218,219,220,221],"Shingrix","Recombinant Zoster Vaccine","Herpes Zoster Vaccine","Herpes Zoster","Shingles","Chronic Kidney Disease","Renal Failure","Kidney Transplant","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":224,"type":43},"2026-04-08",{"date":226,"type":43},"2023-03-02",{"date":228,"type":20},"2029-06",{"name":230,"class":50},"University of Colorado, Denver",4,{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":62,"phases":242,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100532783","phase-3-sotagliflozin-to-slow-kidney-function-decline-in-persons-with-type-1-diabetes-and-diabetic-kidney-disease-100532783","NCT06217302","Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease","Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease","SUGARNSALT","Inclusion Criteria:\n\n* Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.\n* Duration of T1D ≥ 8 years;\n* eGFR based on serum creatinine and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml\u002Fmin\u002F1.73 m2 at screening (with the option of a second eGFR measurement within 4 weeks from the first one if the eGFR was in the range of \\>60 to ≤65 or ≥16 to \\\u003C20 ml\u002Fmin\u002F1.73 m2);\n* a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg\u002Fg at Screening or on repeat measurement within 4 weeks from the first one, or b. First morning void urinary UACR ≥100 mg\u002Fg at Screening or on repeat measurement within 4 weeks and at least one uACR \\>=30 in the previous 2 years while treated with RASB at a stable dose;\n* HbA1c at screening \\\u003C10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);\n* Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, unless contraindicated or not tolerated.\n* Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study.\n* a. Blood pressure ≤155\u002F95 mmHg at screening, or b. BP ≤155\u002F95 mmHg at the end of the run-in period, or c. consistent BP ≤155\u002F95 mmHg on home monitoring during the run-in period, as determined by study site investigator, despite BP values \\>155\u002F95 mmHg in clinic.\n\nExclusion Criteria:\n\n* Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;\n* Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;\n* Use of any SGLT inhibitor in the previous 2 months;\n* Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);\n* Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for \\> 2 months at screening (patients can be rescreened after being on stable dose for \\> 2 months);\n* Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;\n* Known allergies, hypersensitivity, or intolerance to SOTA;\n* History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;\n* History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR \\>1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;\n* Blood beta-hydroxybutyrate (BHB) \\>0.6 mmol\u002FL for \\>2 hours on \\>2 occasions during the Run-in period;\n* Inadequate beta hydroxybutyrate (BHB) testing (\\\u003C50% of the prescribed measurements) during Run-in;\n* History of primary renal glycosuria;\n* History of biopsy-proven non-diabetic chronic kidney disease (CKD);\n* History of kidney transplant or currently on chronic dialysis;\n* Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and\u002For known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and\u002For aspartate aminotransferase (AST) or alanine transaminase (ALT) at screening \\>2 times upper limit of normal, and\u002For total bilirubin at screening \\>1.3 times upper limit of normal).\n* History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;\n* Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.\n* Illicit drug abuse within 6 months of screening;\n* Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);\n* Participation in another interventional clinical research study within 30 days of screening;\n* Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;\n* Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;\n* Any condition that may render the patient unable to comply with study requirements and\u002For complete the study.","75 Years",{"count":19,"type":20},[196],"Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50\u002F50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.",[245,25,246,247],"Diabetic Nephropathies","Diabetes Mellitus Type 1","Heart Failure",[245,25,249,250,251,252,253,254],"Type 1 diabetes","Heart failure","Cardiovascular disease","Glomerular filtration rate","SGLT2 inhibitors","Diabetic kidney disease","2026-03-20",{"date":257,"type":43},"2026-03-24",{"date":259,"type":43},"2024-10-31",{"date":261,"type":20},"2029-05",{"name":263,"class":50},"Alessandro Doria",19,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":129,"sex":16,"minAge":17,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":62,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":293},"100625726","phase-1-a-study-of-eloralintide-ly3841136-in-participants-with-renal-impairment-and-in-participants-with-normal-renal-function-100625726","NCT07426380","A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function","A Phase 1, Multicenter, Parallel-Design, Single Dose, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Eloralintide in Participants With Severe Renal Impairment and End Stage Renal Disease (ESRD) Compared With Participants With Normal Renal Function","Inclusion Criteria:\n\n* Have a body weight of 55 kilograms (kg) or more and a body mass index (BMI) within the range of 19.0 to 40.0 kilograms per square meter (kg\u002Fm²), inclusive\n* Have no significant history of spontaneous or ethanol-induced hypoglycemia\n\nAdditional Inclusion Criteria for Group 1\n\n* Are healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) of at least 90 milliliters per minute (mL\u002Fmin)\n* Have glycated hemoglobin (HbA1c) less than or equal to 6.5% at screening\n\nAdditional Inclusion Criteria for Groups 2 and 3\n\n* Have stable severe renal impairment, assessed by eGFR less than 30 mL\u002Fmin at screening or with end-stage renal disease (ESRD) who have been on a stable hemodialysis (HD) schedule for at least 3 months prior to planned dosing\n* Have acceptable blood pressure and pulse rate\n* If participants have Type 2 Diabetes Mellitus (T2DM), they must have a HbA1c equal to or less than 10.0% at screening\n\nExclusion Criteria:\n\n* Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, any evidence for hepatic impairments\n* Have a current, functioning organ transplant. Nonfunctional renal allografts may be considered\n* Have significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the investigational product; or interfering with the interpretation of data\n\nGroups 2 and 3\n\n* Are receiving continuous HD or peritoneal dialysis.\n* Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before eloralintide administration","85 Years",{"count":274,"type":20},28,[64],"The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to healthy participants. The study drug will be administered subcutaneously (SC) (under the skin).\n\nFor each participant, the study will last about 14 weeks, excluding screening.",[278,279,25,280,281,282],"Kidney Disease","Renal Insufficiency Chronic","Renal Impairment","Renal Insufficiency","End Stage Kidney Disease","2026-03-12",{"date":285,"type":43},"2026-03-13",{"date":287,"type":43},"2026-02-24",{"date":289,"type":20},"2026-10",{"name":291,"class":292},"Eli Lilly and Company","INDUSTRY",2,{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":301,"targetDuration":4,"studyType":62,"phases":303,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":93},"100620482","early-phase-1-addition-of-venetoclax-to-combined-hematopoietic-stem-cell-and-kidney-transplantation-100620482","NCT07358195","Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation","Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy","Recipient Inclusion Criteria:\n\n* Patient ages 18-70\n* Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.\n* Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS. Patient should be in a partial (PR) or complete remission (CR) at the time of the transplant.\n* Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation\n* LVEF \\> 40% as measured by echocardiography or MUGA\n* FEV1, FVC, and DLCO \\> 50% of predicted as measured by standard PFTs\n* Total bilirubin \\\u003C 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all \\\u003C 5x institutions upper limit of normal\n* ABO compatibility in the host vs. graft direction\n* Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.\n* Participants should be on dialysis or have a CrCl ≤ 35 ml\u002Fmin\n* Life expectancy greater than 6 months\n* Recipient ability to understand and provide informed consent\n\nDonor Inclusion Criteria:\n\n* HLA matched or haploidentical relative as defined by 3\u002F6, 4\u002F6, or 5\u002F6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age\n* ECOG performance status 0 or 1\n* Excellent health per conventional pre-donor history (medical and psychosocial evaluation)\n\n  • Acceptable laboratory parameters (hematology in normal or near-normal range; liver function \\\u003C 3 times the upper limit of normal and normal creatinine)\n* Compatible ABO blood group\n* Negative donor lymphocyte cross match\n* No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)\n* Donor ability to understand and provide informed consent\n* Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation\n\nExclusion Criteria:\n\n* Active serious infection\n* Participation in other investigational drug use at the time of enrollment\n* Positivity for active infection with HIV, HCV, or HBV\n* ABO blood group incompatibility in the host-vs-graft direction",{"count":302,"type":20},3,[304],"EARLY_PHASE1","The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.",[170,307,308,309,310],"Stem Cell Transplant","Stem Cell Transplant Complications","Tolerance","Hematologic Cancer","2026-01-13",{"date":313,"type":43},"2026-01-22",{"date":45,"type":20},{"date":316,"type":20},"2029-12",{"name":318,"class":50},"Massachusetts General Hospital",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":327,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":62,"phases":330,"briefSummary":331,"conditions":332,"keywords":337,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":93},"100566830","dialysis-with-expanded-solute-removal-100566830","NCT06660277","DIALysis With EXpanded Solute Removal","DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.","DIALEX","Inclusion Criteria: Inclusion requires that all the following are present:\n\n1. One of:\n\n   1. Age 60 years or older; or\n   2. Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and\n2. Receiving any form of dialysis regularly for the previous 90 days; and\n3. Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and\n4. A valid provincial or territorial health insurance card number.\n\nExclusion Criteria: Patients are ineligible if they meet any of the following criteria:\n\n1. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:\n\n   1. Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or\n   2. Planned to receive HDF; or\n   3. Planned to receive nocturnal HD; or\n   4. Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or\n   5. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or\n   6. An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or\n   7. Another medical, psychosocial, or logistical reason; or\n2. Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise permits concurrent participation in other trials); or\n3. Previously enrolled in this trial; or\n4. Declined participation.","45 Years",{"count":329,"type":20},4800,[105],"The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is:\n\n1\\) Does expanded hemodialysis reduce the risk of death from any cause?\n\nResearchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes.\n\nParticipants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux\u002Fexpanded dialysis filter or a high-flux\u002Fconventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).",[333,334,335,336,278,113,25,109],"Chronic Kidney Disease Requiring Hemodialysis","End-Stage Kidney Disease (ESKD)","Chronic Kidney Disease Requiring Chronic Dialysis","Pragmatic Randomized Controlled Trial",[338,339,340,341,342,343,344],"Nipro Elisio HX","RCT","Dialyzer","Hemodialysis Filter","Super-High Flux Dialyzer","High-Flux Dialyzer","Expanded Hemodialysis","2025-08-22",{"date":347,"type":43},"2025-08-28",{"date":349,"type":43},"2025-08-12",{"date":351,"type":20},"2030-08",{"name":353,"class":50},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":364,"conditions":365,"keywords":370,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":4},"100602424","french-aki-registry-fakir-a-multicenter-study-on-the-in-hospital-management-and-outcomes-of-severe-acute-kidney-injury-in-nephrology-units-100602424","NCT07123324","French AKI Registry (FAKIR): A Multicenter Study on the In-Hospital Management and Outcomes of Severe Acute Kidney Injury in Nephrology Units","Prospective Multicenter Observational Study of the Management and Prognosis of Severe Acute Kidney Injury (AKI) in Nephrology Units: The French AKI Registry (FAKIR)","FAKIR","Inclusion Criteria:\n\n* Age ≥ 18 years at admission\n* Hospitalized in a nephrology ward (standard or intensive nephrology care unit)\n* Diagnosis of acute kidney injury (AKI) stage 2 or 3 according to KDIGO criteria at the time of admission\n* Availability of follow-up data at 3 months (clinical or laboratory)\n\nExclusion Criteria:\n\n* AKI stage 1 only\n* AKI acquired outside the nephrology department without subsequent transfer to nephrology\n* Hospitalized for another reason without documented AKI stage 2 or 3\n* Refusal or opposition to data reuse for research purposes\n* Under legal protection (guardianship or trusteeship) without a representative to provide non-opposition\n* Incomplete medical records preventing collection of required baseline data",{"count":363,"type":20},750,"Acute Kidney Injury (AKI) is a common and serious condition in hospitalized patients, especially when it reaches stages 2 or 3 according to the KDIGO classification. These severe forms are associated with high mortality, a risk of progression to chronic kidney disease (CKD), and frequent cardiovascular complications. However, current data on how nephrologists manage these patients during hospitalization-and how these practices influence long-term outcomes-are limited and heterogeneous.\n\nThe FAKIR study (French AKI Registry) is a prospective, multicenter, non-interventional observational study designed to describe the clinical management of patients admitted to nephrology departments for AKI stage 2 or 3 and to assess their renal and cardiovascular outcomes up to one year. The study hypothesizes that better characterization of in-hospital practices and patient trajectories will help identify predictors of renal recovery, progression to end-stage renal disease, and major cardiovascular events.\n\nPatients will be followed during hospitalization and at 3, 6, and 12 months to assess renal function, mortality, cardiovascular events, and rehospitalizations. This registry aims to provide real-life, multicenter data to support future guidelines and the development of structured post-AKI care pathways.",[366,170,367,368,369],"Acute Kidney Injury","Cardiorenal Syndrome","Renal Replacement Therapies","Hospitalizations",[371,372,373,374,375,376,377,378,379,380],"Kidney injury","Renal function recovery","Dialysis initiation","Kidney biopsy","Cardiovascular complications","Nephrology care","Renal prognosis","Renal cohort","Kidney follow-up","Kidney disease progression","2025-08-07",{"date":383,"type":43},"2025-08-14",{"date":385,"type":20},"2025-11-01",{"date":387,"type":20},"2028-08-01",{"name":389,"class":50},"University Hospital, Strasbourg, France",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":62,"phases":400,"briefSummary":401,"conditions":402,"keywords":406,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":93},"100461044","intravenous-vs-oral-hydration-to-reduce-the-risk-of-post-contrast-acute-kidney-injury-after-intravenous-contrast-enhanced-computed-tomography-in-patients-with-severe-chronic-kidney-disease-100461044","NCT05283512","Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease","Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease (ENRICH): A Randomized Controlled Trial","ENRICH","Inclusion Criteria:\n\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Scheduled for elective IV CECT\n* Age ≥ 18\n* Signed informed consent\n\nExclusion Criteria:\n\n* Allergy to Iodine\n* Pregnancy\n* Active dialysis treatment\n* Acute infectious or inflammatory disease\n* Acute pre- and\u002For post-renal kidney failure\n* Unable to understand study information",{"count":399,"type":20},254,[105],"The use of contrast media (CM) poses a risk of post-contrast acute kidney injury (PC-AKI), especially among patients chronic kidney disease (CKD). International guidelines recommend intravenous (IV) hydration with isotonic 0.9% NaCl for three-four hours pre-contrast and four-six hours post-contrast. Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD (eGFR 30-60 mL\u002Fmin\u002F1.73 m2). However, no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2).\n\nThus, the main focus of this trial is to evaluate IV hydration vs. oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD, who are scheduled for an elective contrast-enhanced CT-scan (CECT) with IV contrast-administration.\n\nOur research hypotheses consist of the following:\n\n1. Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 0.9% NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT.\n2. NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI, dialysis, renal adverse events, hospitalization, progression in CKD-symptoms, and all-cause mortality.",[403,404,25,405],"Contrast-induced Nephropathy","Kidney Injury","Risk Reduction",[407,408,409,410,411,412,413],"Intravenous","Contrast material","Computed Tomography","Cardiac CT","Prophylaxis","Oral Hydration","IV-hydration","2025-07-29",{"date":416,"type":43},"2025-08-01",{"date":418,"type":43},"2022-04-20",{"date":420,"type":20},"2027-12-31",{"name":422,"class":50},"Odense University Hospital",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":62,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":302},"100540258","first-in-human-study-to-examine-safety-of-a-new-peritoneal-dialysis-device-weakid-in-end-stage-kidney-disease-patients-100540258","NCT06314503","First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients","Clinical Validation of a Continuous Flow Peritoneal Dialysis System With Dialysate Regeneration","CORDIAL","Inclusion Criteria:\n\n* ≥18 years of age\n* Treated with PD for at least 3 months prior to enrolment\n* Well-functioning peritoneal catheter and no peritoneal catheter replacement for at least a month prior to enrolment\n* No PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished).\n* Previous or current use of Extraneal® with no contra-indications\n* Capable of understanding the patient information sheet and informed consent form (ICF) and give informed consent\n* Willing and able to comply with all study procedures and attend all study visits\n\nExclusion Criteria:\n\n* Patients who are unable to provide informed consent\n* Patients who are unable to comply with study procedures\n* Patients who received renal replacement therapy other than conventional PD less than 8 weeks prior to enrolment\n* Patients who participated in an intervention trial less than 8 weeks prior to enrolment or are currently participating in an intervention trial. Patients in an observational study without any interventions or in post-market surveillance do not need to be excluded.\n* Patients with a PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished)\n* Patients with peritoneal catheter dysfunction or mechanical issues less than one month prior to enrolment\n* Patients who have never used Extraneal® dialysis fluid or have a contra-indication for Extraneal®: a known allergy to cornstarch or icodextrin; maltose or isomaltose intolerance; glycogen storage disease\n* Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)\n* Patients with haemoglobin concentrations \\\u003C 6.2 mmol\u002FL (\\\u003C 10 g\u002FdL) less than 8 weeks prior to enrolment\n* Patients with hyperkalemia (\\> 6.0 mmol\u002FL) or hyponatremia (\\\u003C 130 mmol\u002FL) in the 8 weeks prior to enrolment\n* Patients with hypocalcemia (plasma total calcium concentration corrected for albumin \\\u003C2.20 mmol\u002FL or ionized calcium \\\u003C1.15 mmol\u002FL) or hypomagnesemia (plasma magnesium concentration \\\u003C0.70 mmol\u002FL) in the 8 weeks prior to enrolment\n* Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and\u002For effectiveness of the study\n* Female patients who are either (planning to become) pregnant within the study period or breast feeding\n* Patients with a life expectancy \\\u003C3 months\n* Anticipated living donor kidney transplantation \\\u003C3 months",{"count":432,"type":20},12,[105],"The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid.\n\nThe study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment.\n\nThe main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions.\n\nParticipants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber.\n\nParticipants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).",[113,25,436],"Chronic Kidney Diseases",[438,439,440],"Peritoneal Dialysis","First-in-human","Medical device","2025-07-15",{"date":443,"type":43},"2025-07-18",{"date":445,"type":43},"2024-01-22",{"date":447,"type":20},"2025-12-31",{"name":449,"class":50},"UMC Utrecht",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":62,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":479},"100329735","pragmatic-randomised-trial-of-high-or-standard-phosphate-targets-in-end-stage-kidney-disease-phosphate-100329735","NCT03573089","Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)","An Investigator-initiated, International, Multi-centre, Prospective, Randomized, Open-label, Parallel-group, Superiority, and Pragmatic Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis.","PHOSPHATE","Inclusion Criteria:\n\n1. Age ≥45 years, or Age ≥18 years with diabetes,\n2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,\n3. Currently prescribed at least one phosphate-lowering medication at any dose\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Elective kidney transplantation scheduled,\n2. Concomitant major illness \u002F comorbidity that may result in death in the next 6 months in the view of the treating physician,\n3. Participation in an interventional study that is likely to affect serum phosphate concentration.",{"count":459,"type":20},3600,[105],"During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.",[25,463],"Hyperphosphatemia",[465,466,467,468,469,470,463],"Renal dialysis","Randomised controlled trial","Bone markers","Cardiovascular risk factors","Phosphate lowering agent","End stage kidney disease","2025-06-29",{"date":473,"type":43},"2025-07-01",{"date":475,"type":43},"2019-12-10",{"date":152,"type":20},{"name":478,"class":50},"The University of Queensland",115,{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":62,"phases":490,"briefSummary":491,"conditions":492,"keywords":496,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":93},"100585530","phase-1-roxadustats-effect-on-heart-nutrition-and-inflammation-in-hemodialysis-patients-100585530","NCT06903559","Roxadustat's Effect on Heart, Nutrition, and Inflammation in Hemodialysis Patients","Effect of Roxadustat on Cardiovascular System and Malnutrition-Inflammation-Atherosclerosis (MIA) Syndrome in Hemodialysis Patients: A Randomized Controlled Study","ROXA-HD-MIA","Inclusion Criteria:\n\n* Age of patient is more than 18.\n* Patients who are willing to sign informed consent.\n* Patients with ESKD on chronic hemodialysis for more than 3 months.\n\nExclusion Criteria:\n\n* Current pregnancy or lactation.\n* Patients with pre-existing malignancy.\n* Patients with psychosis or on hypnotics.\n* Refuse to participate in the study.\n* Known history of hematological disorders or other known causes for anemia other than CKD or dialysis.\n* Patients with severe cardiovascular disease",{"count":489,"type":20},46,[64,65],"Patients with kidney failure who require hemodialysis often suffer from anemia (low red blood cell count), heart and blood vessel problems, and a condition involving poor nutrition, inflammation, and hardening of the arteries (called MIA syndrome). Standard treatments for anemia often involve injections and iron supplements. This study aims to see if a newer oral medication, Roxadustat, works better than these standard treatments not only for anemia but also for improving cardiovascular health and the MIA syndrome.\n\nParticipants in the study will be randomly assigned (like by chance) to one of two groups. One group will receive Roxadustat, while the other group will continue with their conventional anemia treatment. Researchers will compare the effects on heart function, markers of nutrition and inflammation, and anemia levels in both groups over a 6-month period.",[25,493,494,495],"Malnutrition-Inflammation Syndrome","Anemia in End Stage Renal Disease","Cardiovascular Diseases (CVD)",[497,109,498,499,500],"Roxadustat","Renal Anemia","Cardiovascular Diseases","Malnutrition-Inflammation-Atherosclerosis Syndrome","2025-05-08",{"date":503,"type":43},"2025-05-13",{"date":505,"type":43},"2025-04-15",{"date":385,"type":20},{"name":508,"class":50},"Mansoura University",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":516,"targetDuration":518,"studyType":22,"phases":4,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":93},"100194055","repository-of-novel-analytes-leading-to-autoimmune-inflammatory-and-diabetic-nephropathies-renal-aid-100194055","NCT01802034","Repository of Novel Analytes Leading to Autoimmune, Inflammatory and Diabetic Nephropathies (RENAL AID)","RENAL AID","Key Inclusion Criteria:\n\nAll Groups:\n\n* Males or females\n* 18 years of age and older\n* Willing and able to provide informed consent\n\nNative Biopsy Tissue Group:\n\n\\- Require an initial kidney biopsy for medical necessity\n\nNative Kidney, Non-tissue Group:\n\n* Previously had a kidney biopsy and the tissue is not stored in this biorepository; or\n* Have diabetes and kidney disease and have not had a kidney biopsy\n\nAllograft Tissue Group:\n\n\\- Have undergone a renal transplant and require a transplant biopsy for either surveillance or \"for-cause\" indications.\n\nKey Exclusion Criteria for all Groups:\n\n\\- Inability to provide informed consent.",{"count":517,"type":20},2000,"10 Years","A central goal of this data repository is to collect data from a large population of subjects with a variety of renal disease states. Cohorts will include subjects with diabetes, inflammatory\u002Fautoimmune and transplant related renal conditions. Additionally, the repository will have the capacity to store biospecimens and electronic data in control subjects without established renal disease. This initiative will provide an opportunity to compare data from various disease states and controls with the objective of determining clinical and biological factors that predict disease progression, response to therapy and identify discriminating noninvasive clinical and biological features that predict renal biopsy findings.",[521,25,522,523,524],"Kidney Diseases","Diabetic Nephropathy","Lupus Nephritis","Glomerulonephritis, IGA","2025-04-01",{"date":527,"type":43},"2025-04-04",{"date":529,"type":4},"2013-02",{"date":531,"type":20},"2028-08",{"name":533,"class":50},"The Rogosin Institute",{"id":535,"slug":536,"hasResults":11,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":62,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":554,"leadSponsor":556,"locationsCount":4},"100585540","phase-1-pentoxifylline-for-vascular-calcification-in-kidney-disease-100585540","NCT06903689","Pentoxifylline for Vascular Calcification in Kidney Disease","Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients","PTX-CALC-CKD","Inclusion Criteria:\n\n* Estimated Glomerular Filtration Rate (eGFR) less than 60 ml\u002Fmin\u002F1.73 m² and greater than or equal to 15 ml\u002Fmin\u002F1.73 m².\n* Adult patients, age 18 years or older.\n* Diagnosis of Chronic Kidney Disease (CKD).\n* Willing and able to provide informed consent.\n\nExclusion Criteria:\n\n* Patients currently undergoing regular hemodialysis.\n* History of kidney transplantation or are kidney transplant recipients.\n* Pregnant females.\n* Patients with a history of coronary artery bypass grafting (CABG).\n* Known allergy or contraindication to pentoxifylline.\n* Inability to comply with study procedures or attend follow-up visits.",{"count":543,"type":20},80,[64,65],"This study is research to find out if the drug pentoxifylline can help prevent or lessen the problem of blood vessel hardening (vascular calcification) in people with chronic kidney disease (CKD). People with CKD are at higher risk for heart problems and blood vessel hardening. Vascular calcification happens when calcium builds up in the blood vessels, making them stiff. Pentoxifylline is a drug that might have helpful effects that could reduce this hardening. In this study, some CKD patients will receive pentoxifylline in addition to their usual medications, while others will only receive their usual medications. The researchers will then compare the amount of vascular calcification in both groups over 6 months to see if pentoxifylline makes a difference. The goal is to learn if pentoxifylline could be a new way to protect the blood vessels of people with chronic kidney disease.",[208,547,25],"Vascular Calcification",[25,547,549,550],"Pentoxifylline","CKD","2025-03-25",{"date":525,"type":43},{"date":505,"type":20},{"date":555,"type":20},"2025-10-30",{"name":508,"class":50},{"id":558,"slug":559,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":129,"sex":16,"minAge":564,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":62,"phases":566,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":581,"locationsCount":4},"100552908","vr-guided-mindfulness-for-eskd-caregiver-well-being-100552908","NCT06479200","VR-Guided Mindfulness for ESKD Caregiver Well-Being","Protocol for Pilot Randomized Controlled Trial: Virtual Reality-Guided Mindfulness Intervention on Psychosocial Well-Being of End-Stage Kidney Disease Caregivers","Inclusion Criteria:\n\n* Age 21 years or older\n* Primary caregiver of a patient with end-stage kidney disease (ESKD) (stage 4 \\& 5 with - estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Proficient in English\n\nExclusion Criteria:\n\n* Known visual or hearing impairments\n* History of motion sickness\n* Active psychosis or suicidal ideation\n* Current regular mindfulness practice\n* History of seizure, stroke, or head injury","21 Years",{"count":103,"type":20},[105],"This pilot randomized controlled trial aims to evaluate the efficacy and feasibility of a virtual reality (VR)-guided mindfulness intervention for caregivers of patients with end-stage kidney disease (ESKD). Thirty ESKD caregivers will be randomly assigned to either a 6-week VR-guided mindfulness intervention or a sham VR control group. The study will assess changes in caregiver burden, stress, anxiety, depression, quality of life, and mindfulness using validated questionnaires. Feasibility outcomes, including recruitment, retention, adherence, and participant experiences, will also be evaluated. The findings will inform the design of a future larger-scale trial and may lead to the development of an accessible, technology-based support option for ESKD caregivers.",[25],[570,571,572,573,574],"virtual reality","mindfulness","caregiver burden","end-stage kidney disease","pilot randomized controlled trial","2024-06-26",{"date":577,"type":43},"2024-06-28",{"date":579,"type":20},"2024-08-01",{"date":416,"type":20},{"name":582,"class":50},"Alexandra Hospital",{"id":584,"slug":585,"hasResults":11,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":62,"phases":593,"briefSummary":594,"conditions":595,"keywords":596,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":4},"100298085","phase-1-a-two-part-phase-2a-study-of-rvx000222-in-patients-with-end-stage-renal-disease-treated-with-hemodialysis-100298085","NCT03160430","A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis","A Two-Part Phase 2a Study in Patients With End-Stage Renal Disease Treated With Hemodialysis; Part A is an Open-Label Study Arm to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of 100 mg RVX000222; and Part B is a Double-Blind, Randomized, Placebo-Controlled, Sequential Cross-Over Study Arm to Evaluate the Efficacy, Safety, and Pharmacokinetics of RVX000222","Inclusion Criteria:\n\n1. Men or women ≥18 and ≤80 years of age.\n2. Diagnosis of end-stage renal disease and receiving hemodialysis an average of three (3) times per week for at least ninety (90) days prior to Enrollment\u002FVisit 2.\n3. Clinically stable, in the judgment of the investigator.\n4. Female subjects must meet one of the following:\n\n   1. If of childbearing potential, must have a negative serum pregnancy test and be willing and able to use medically acceptable non-hormonal method of birth control (non-hormonal intrauterine device, condom, or diaphragm) or remain abstinent from Screen until Follow-up Visit, or\n   2. Be of non-child-bearing potential: post-surgical sterilization (hysterectomy or a bilateral oophorectomy) or post-menopausal. Post-menopausal is defined as amenorrhea for ≥2 years at Screen\u002FVisit 1.\n5. In the view of the investigator, during the course of the trial, subject is expected to:\n\n   1. remain on unchanged standard of care medication from 4 weeks prior to Enrollment\u002FVisit 2.\n   2. not require hospitalization for any condition other than routine hemodialysis.\n6. Have given signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Planned major surgery in the next 4 months, including renal transplant, from Enrollment\u002FVisit 2.\n2. Major surgery, in the judgement of the investigator, within 12 weeks before enrollment\u002FVisit 2 (excluding vascular access surgery).\n3. Hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack or peripheral arterial disease within 6 months before Enrollment\u002FVisit 2.\n4. New York Heart Association (NYHA) Classification, Class III or IV Heart Failure at Screen\u002FVisit 1.\n5. Diastolic blood pressure \\>110 mm Hg or systolic blood pressure \\>180 mm Hg during screen.\n6. Currently receiving antibiotic therapy for systemic infection.\n7. In the judgement of the Investigator, evidence of active hepatitis. Hepatitis serology testing will be performed at Screen\u002FVisit 1.\n8. History of malignancy of any organ system, treated or untreated, within the past 2 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.\n9. Red blood cell (RBC) transfusions within 12 weeks before Enrollment\u002FVisit 2.\n10. Current or recent (within 12 months prior to Visit 1) treatment with immunosuppressants (e.g., cyclosporine).\n11. Use of fibrates at any dose or niacin\u002Fnicotinic acid 250 mg or more within 30 days prior to Screen\u002FVisit 1.\n12. Diagnosis of systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).\n13. Hemoglobin \\\u003C9.5 g\u002FdL at Screen\u002FVisit 1.\n14. Alanine aminotransferase (ALT) \\>1.5 x upper limit of normal (ULN) at Screen\u002FVisit 1.\n15. Bilirubin \\>1.0 x ULN at Screen\u002FVisit 1.\n16. Pregnant or breast-feeding women.\n17. Any condition which, in the opinion of the investigator, may place the subject at higher risk from his\u002Fher participation in the study, or is likely to prevent the subject from complying with the requirements of the study or completing the study.\n18. Treatment with an investigational agent or device within 30 days or 5 half-lives before Enrollment\u002FVisit 2 or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study.\n19. History of noncompliance with medical regimens or unwillingness to comply with the study protocol.\n20. In the judgement of the Investigator, any disorder that may impact the ability to give informed consent for participation in this study.\n21. Any condition that, in the opinion of the investigator, would confound the evaluation and interpretation of efficacy and\u002For safety data.\n22. Persons directly involved in the execution of this protocol.\n\n    Exclusion Criteria, Part A Only:\n23. Are unwilling to abstain from alcoholic beverages, caffeine or xanthine-containing products (e.g., tea, coffee, chocolate, cola), and use of nicotine products from 24 hours prior to Clinical Research Unit (CRU) admission to 48 hours post RVX000222 dose administration.\n\nExclusion Criteria, Part B Only:\n\n23\\. Parathyroid hormone, intact (PTH, intact) \\\u003C150 pg\u002FmL or \\>800 pg\u002FmL at Screen\u002FVisit 1.","80 Years",{"count":592,"type":20},44,[64,65],"This is a multi-center, two-part study; Part A and Part B. Part A of the study is an open-label, single-dose pharmacokinetic (PK) evaluation of 100 mg RVX000222 on dialysis and non-dialysis days in eight (8) End Stage Renal Disease (ESRD) patients who receive hemodialysis as standard of care.\n\nPart B of the study is a double-blind, placebo-controlled study in up to thirty six (36) ESRD patients receiving hemodialysis using a sequential cross-over design with RVX000222 at a daily oral dose of 100 mg b.i.d. (200 mg per day) or matching placebo in combination with SoC.\n\nThe primary objective of the study is to evaluate if treatment with RVX000222 in combination with standard of care (SoC) decreases plasma alkaline phosphatase in comparison to placebo and SoC.",[25],[597,598,81,599,600,601,602],"Chronic Kidney Failure","ESRD","End-Stage Renal Disease","Renal Disease, End-Stage","Renal Failure, Chronic","Renal Failure, End-Stage","2023-11-14",{"date":605,"type":43},"2023-11-15",{"date":607,"type":20},"2024-11-22",{"date":609,"type":20},"2026-11-22",{"name":611,"class":292},"Resverlogix Corp",{"id":613,"slug":614,"hasResults":11,"nctId":615,"briefTitle":616,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":11,"sex":16,"minAge":618,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":62,"phases":621,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":93},"100494530","phase-4-the-effect-of-intravenous-iron-therapy-and-erythropoiesis-stimulation-agent-combination-on-renal-transplant-outcomes-100494530","NCT05719376","The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes","Inclusion Criteria:\n\n1. living donor transplantation (age\\>19)\n2. Ferritin\\\u003C700㎍\u002FL, TSAT\\\u003C40%\n\nExclusion Criteria:\n\n1. CDC(+), FXM(+)\n2. Active infection\n3. Hematologic malignancy, monoclonal gammaglobulin Dz, Hematologic Dz induced anemia\n4. Receiving treatment of malignant tumor\n5. HIV (+)\n6. ALT, AST \\> 3 times upper limit of normal","20 Years",{"count":620,"type":20},302,[622],"PHASE4","RBC transfusion (RBCT) after kidney transplantation(KT) is about 50%. Anemia is common after kidney transplant surgery due to intraoperative blood loss, delayed graft function, and side effects of immunosuppressive drugs. However, due to exposure to non-self human leukocyte antigens (HLA) from blood transfusion, there is a risk of sensitization to HLA through the production of anti-HLA antibodies. In renal transplant patients, exposure to non-self HLA antigens due to RBCT can lead to the generation of donor-specific antibodies (DSA) against renal allograft donors. Patients who have undergone KT are frequently exposed to RBCT, and immunologic damage resulting from this can be an important cause of loss of graft kidney function. Therefore, there should be a more careful review of the risk associated with RBCT on KT recipients.\n\nOf the 16,191 Koreans who underwent KT between 2008 and 2017, 59.7% received transplant-related blood transfusions. As a result of analyzing 13,871 Koreans who underwent KT between 2007 and 2015, the overall graft failure rate was 15.5%, and the hazard ratio of survival rate according to RBCT before and after KT increased as the amount of transfusion increased. RBCT before and after KT was independently associated with graft failure and death. Therefore, research on treatment methods that can effectively reduce blood transfusion in transplant patients is absolutely necessary. About 30-60% of patients undergoing major surgery show preoperative anemia, which causes blood transfusions, complications during hospitalization, prolonged hospitalization, and delayed recovery. The most common cause of anemia is iron deficiency. In particular, an increase in hepcidin, a major regulator of iron metabolism, reduces intestinal iron absorption and promotes iron sequestering by macrophages, resulting in a state of functional iron deficiency. Therefore, oral iron intake as a treatment for anemia in surgical patients is not effective. Although the safety and clinical superiority of high-dose intravenous iron therapy have been demonstrated in patients with chronic renal failure, the effect of this drug on blood transfusion of pre- and post-kidney transplant surgery has not been studied. Therefore, this study aims to verify the effectiveness and stability of the combined administration of intravenous(IV) iron and erythropoiesis-stimulating agents(ESA) before and after KT for patients who perform KT for end-stage kidney disease(ESKD). The investigators will analyze hemoglobin, transferrin saturation, ferritin changes, and transfusion requirements according to the combined administration of IV iron and ESA before and after surgery of kidney transplant patients. Also, the investigators evaluate whether a treatment combining IV iron and ESA will be possible as an alternative blood transfusion treatment and its effect on the clinical prognosis of KT recipients. In particular, the effect on the function of the graft kidney, immunological outcomes-DSA, antibody-mediated rejection, and survival rate will be analyzed. Also, the investigators will analyze the change in expression of hepcidin and oxidative stress markers before and after kidney transplantation and the mechanism of expression according to the combined administration of IV iron and ESA. This study is a multicenter(including 3 centers), open-label, prospective, and randomized clinical trial. 302 patients undergoing living-donor KT for ESKD are randomly assigned in a 1:1 ratio to an experimental group actively using IV iron and ESA, and a control group receiving conventional anemia treatment for 42 months from the time of IRB approval. Participants selected for the experimental group will be given a total of 1000 mg of IV Monofer(iron isomaltoside); each 200 mg dose on 28, 21, and 7 days before kidney transplantation, on the day of surgery, and 7 days after surgery. In the case of ESA, it is freely used according to the criteria up to 7 days before transplantation and subcutaneously injected with 120 mcg of Mircera(methoxy polyethylene glycol-epoetin beta) between 7 days before surgery and a day before surgery. In the control group, IV Monofer is administered only 28 days before surgery according to the set criteria. Mircera is also freely used in the control group according to the criteria up to 7 days before KT but not used between 7 days before surgery and a day before surgery.",[25],"2023-02-05",{"date":627,"type":43},"2023-02-09",{"date":629,"type":20},"2023-02",{"date":631,"type":20},"2026-06",{"name":633,"class":50},"Yonsei University"]