[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-transplant-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-transplant-complications":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,44,65,96,117,146,172,201,227,250,284,307,330,358,380,401,423,442,466,494,522,541,564,599,624],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100557503","immune-registry-for-bk-in-kidney-transplant-recipients-100557503",false,"NCT06538961","Immune Registry for BK in Kidney Transplant Recipients","Immune Registry for BK (Polyomavirus Hominis 1) in Kidney Transplant Recipients","Inclusion Criteria:\n\n* Adult (\\>18 years old) male and female, deceased donor KT recipients\n* Will include single organ transplants.\n* Each participant must also have recently been diagnosed with BK viremia.\n* In addition to the aforementioned inclusion criteria, each participant in the sub-study must also have recently been diagnosed with BK viremia or have difficult-to-treat BKV \\> 3 logs (BKV log does not decrease by more than 1 log copy\u002Fml drop on second per protocol lab).\n\nExclusion Criteria:\n\n* Prisoners will not be included in the study\n* Multi-organ transplants and pregnant women","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","24 Months","OBSERVATIONAL","Kidney transplantation (KT) is the best treatment modality available to date for patients with advanced kidney disease and the success of KT is dependent on maintaining a selective intricate balance between the risk of rejection and infections in KT recipients. BK virus is an important clinical infection affecting the post-transplant outcomes in KT recipients. BK nephropathy can affect 8-15% of patients after KT causing acute kidney injury, increased risk of rejection and fibrosis leading to additional hospital stays, increasing overall health care cost burden, and in some cases graft loss. The exact pathogenesis and treatment options for BK nephropathy are not clearly understood. It is debatable whether BK nephropathy is a full fledge donor-derived infection or reactivation of the recipient's latent infection. Irrespective of etiology, the common consensus is that treatment of BK virus infection depends on the selective restoration of host immune responses and balancing the risk of rejection vs worsening of infection.",[26,27],"BK Virus Infection","Kidney Transplant; Complications",[29,30],"Immune Registry","BK in Kidney Transplant Recipients","RECRUITING","2026-06-25",{"date":34,"type":35},"2026-06-26","ACTUAL",{"date":37,"type":35},"2024-05-29",{"date":39,"type":21},"2026-07",{"name":41,"class":42},"Virginia Commonwealth University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":43},"100569021","feasibility-study-for-the-comprehensive-overweightobesity-management-pre-kidney-transplant-compkt-program-100569021","NCT06688825","Feasibility Study for the Comprehensive Overweight\u002FObesity Management Pre-Kidney Transplant (COMPKT) Program","Inclusion Criteria:\n\n* on the waiting list for kidney transplant at VCUHS\n* BMI greater than 35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Children, prisoners, pregnant women",{"count":51,"type":21},30,"INTERVENTIONAL",[54],"NA","This project will be a single-arm feasibility study, with a treatment intervention that includes three interrelated components: (1) patient education using a proven weight loss curriculum, and (2) technology tools for making healthy lifestyle choices.",[27,57],"Obesity","2026-06-05",{"date":60,"type":35},"2026-06-08",{"date":62,"type":35},"2024-09-16",{"date":39,"type":21},{"name":41,"class":42},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":74,"studyType":23,"phases":4,"briefSummary":75,"conditions":76,"keywords":83,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100633844","vascular-complications-after-kidney-transplantation-100633844","NCT07531966","Vascular Complications After Kidney Transplantation","Vascular Complications After Kidney Transplantation: A Prospective National Multicenter Study - The DAN-PTRAIII Study","DAN-PTRAIII","Inclusion Criteria:\n\n1\\. At least one of the following clinical criteria (1 or 2) must be fulfilled:\n\n1. Graft dysfunction, defined by at least one of the following:\n\n   * Acute reduction in estimated glomerular filtration rate (eGFR) \\>15% on two consecutive measurements at least 2 weeks apart, with other causes excluded (rejection, obstruction, infection).\n   * eGFR \\\u003C50% of the expected value 30 days after kidney transplantation of unknown cause.\n   * Decline in eGFR \\>30% after initiation of an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.\n2. Persistent resistant hypertension for more than 6 weeks after kidney transplantation, defined as:\n\n   * 24-hour ambulatory systolic blood pressure \\>130 mmHg despite treatment with at least three classes of antihypertensive medication at maximally tolerated doses (including diuretics, if tolerated).\n\nTogether with at least one of the following radiological criteria:\n\n1. CT or MR angiography demonstrating a lumen reduction ≥50%.\n2. Doppler ultrasound showing:\n\n   1. Peak systolic velocity in the renal artery ≥200 cm\u002Fs and a renal renal ratio (velocity at stenosis \u002F velocity in distal artery) \\>4.\n   2. Acceleration time \\>70 ms in intrarenal arteries.\n\n2\\. In cases of strong clinical suspicion of a vascular complication where CT or MR angiography cannot reliably exclude graft artery or vein stenosis, patients may be referred for confirmatory invasive investigations.\n\nBefore PTA, catheter-based angiography and translesional pressure measurements are performed to confirm whether the patient meets the radiological eligibility criterion for PTA:\n\n1. Stenosis ≥70%.\n2. Stenosis 50-69% if at least one of the following criteria is met:\n\n   * Mean translesional pressure gradient ≥10 mmHg.\n   * Systolic pressure gradient ≥20 mmHg.\n   * Renal Pd\u002FPa ≤0.8.\n   * If pressure measurements cannot be obtained, treatment is based on the operator's clinical judgement.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. Concurrent biopsy demonstrating rejection requiring treatment.\n3. Pregnancy.\n4. Previous PTA of the same vessel.\n5. Patients unable to tolerate any form of antithrombotic therapy and therefore not eligible for stent placement.",{"count":20,"type":21},"10 Years","* To determine the incidence of arterial inflow problems and venous outflow problems as causes of impaired renal function and\u002For treatment-resistant hypertension after kidney transplantation, when all kidney-transplant recipients in Denmark are evaluated according to uniform, well-defined clinical criteria.\n* To investigate the efficacy and safety of catheter-based balloon treatment (percutaneous transluminal angioplasty, PTA) for these vascular complications, of which transplant renal artery stenosis is by far the most common.\n* To assess whether novel imaging and functional diagnostic methods can predict treatment response.",[77,27,78,79,80,81,82],"Kidney Transplant Recipient","Transplant Renal Artery Stenosis","Renovascular Disease","Renal Transplant Graft Failure","Renovascular Hypertension","Heart Failure",[27,78,84,85],"renovascular disease","Percutaneous transluminal angioplasty","2026-05-26",{"date":88,"type":35},"2026-05-27",{"date":90,"type":35},"2026-05-22",{"date":92,"type":21},"2031-06-01",{"name":94,"class":42},"University of Aarhus",3,{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":52,"phases":105,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":43},"100493921","double-voiding-and-post-transplant-uti-100493921","NCT05711446","Double Voiding and Post-transplant UTI","A Randomized Trial of Double Voiding Versus Usual Voiding to Reduce the Incidence of Urinary Tract Infections in Kidney Transplant Recipients","Inclusion Criteria:\n\n* All adult kidney transplant recipients who undergo routine follow-up at the New York Presbyterian - Weill Cornell Medicine (NYP-WCM) Transplant Clinic.\n\nExclusion Criteria:\n\n* Kidney transplant recipients who are discharged after a transplant with an indwelling catheter (Foley)",{"count":104,"type":21},438,[54],"Urinary tract infections (UTI) are common in kidney transplant recipients and are an important cause of illness and hospital admissions. Past studies have shown that about 1 out of 5 of newly transplanted patients develop UTI within their first 3 months of transplantation. Such UTIs increase the risk for blood stream infection and acute rejection of the kidney, Improvements in urinary voiding techniques may reduce the frequency of UTI. The purpose of this study is to evaluate the benefits of \"double voiding\" in kidney transplant recipients.",[108,27],"Urinary Tract Infections","2026-05-19",{"date":90,"type":35},{"date":112,"type":35},"2023-04-07",{"date":114,"type":21},"2027-05",{"name":116,"class":42},"Weill Medical College of Cornell University",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":52,"phases":125,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":43},"100520676","phase-2-the-effect-of-finerenone-in-kidney-transplantion-recipients-the-effektor-study-100520676","NCT06059664","The EFfect of FinErenone in Kidney TransplantiOn Recipients: The EFFEKTOR Study","Clinical Trial Inclusion Criteria:\n\n* Adult kidney transplant recipients ≥ 18 years\n* 1 to 10 years post kidney transplantation from a deceased or living donor\n* Stable kidney allograft function (within 20% baseline eGFR) and based on the clinical judgement of the investigator\n* Preserved kidney allograft function defined as an eGFR ≥ 25 mL\u002Fmin\u002F1.73 m\n* Urine albumin:creatinine ratio (UACR) ≥30 ug\u002Fmg\n* Ability of the participant, or their legally authorized representative, to provide informed consent\n* Contraceptive requirements:\n* Women of non-childbearing potential do not need to undergo pregnancy testing or agree to use adequate contraception. Non-childbearing potential is defined as documented hysterectomy, bilateral salpingectomy, oophorectomy or postmenopausal females (amenorrhea for 12 months without an alternative medical cause). A single high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state.\n* Women of childbearing potential can only be included if a pregnancy test is negative at the screening visit and if they agree to use adequate contraception during the study and until 8 weeks after the last study intervention dose. Adequate contraception is defined as an intrauterine device, implant or combined oral contraceptive with a physical barrier (e,g., condom).\n\nAdditional Inclusion Criteria for Kidney Biopsy Sub-study:\n\n* Willingness to undergo research study biopsies at screening and following the 12 month treatment period\n* Ability to safely discontinue antiplatelet or anticoagulant treatments\n* No known intrinsic bleeding diathesis\n* Hemoglobin \\>9.0 g\u002FdL; Platelets \\> 100,000; International Normalised Ratio (INR) \\\u003C1.4 on the day of kidney biopsy\n* Body mass index \\\u003C40\n* Blood pressure controlled on the day of biopsy to \\\u003C160\u002F90\n\nMedical Condition Exclusion Criteria:\n\n* Documented recurrent lupus nephritis, ANtineutrophilic Cytoplasmic Antibody (ANCA) vasculitis, membranoproliferative glomerulonephritis (including C3 glomerulopathy)\n* History of solid organ transplantation other than kidney\n* Acute kidney injury requiring dialysis within 6 months prior to screening\n* Uncontrolled hypertension with a sitting Systolic Blood Pressure (SBP) ≥180 mmHg or Diastolic Blood Pressure (DBP) ≥100 mmHg\n* Any indication for treatment with a steroidal MRA\n* UACR \\>3500 mg\u002Fg at screening. This may be reassessed if one of the three first morning urine samples is \\>3500 mg\u002Fg at the screening visit\n* CV event within 3 months prior to screening (heart failure requiring acute care, myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, elective coronary artery bypass grafting)\n* Elective percutaneous coronary intervention within 1 month prior to screening\n* Known hypersensitivity to the study treatment\n* Addison's disease\n* Hepatic insufficiency classified as Child-Pugh C\n* Pregnancy, breast feeding or intention to become pregnant\n\nConcomitant Therapies Exclusion Criteria:\n\n* Concomitant therapy with spironolactone, eplerenone, sacubitril\u002Fvalsartan combination, or potassium-sparing diuretic which cannot be discontinued at least 2 weeks prior to screening\n* Simultaneous use of Angiotensin-Converting Enzyme Inhibitors (ACEI) and Angiotensin Receptor Blockers (ARB), without being able to discontinue one of these at least 2 weeks prior to screening\n* Use of potent CYP3A4 inhibitors or inducers (to be stopped at least 7 days before randomization).\n\nOther Exclusion Criteria:\n\n* Participation in the MRI Study is excluded for certain pacemakers, electronic implants, shrapnel of the eye and certain types of aneurysm clips.\n* Any other history, condition, or therapy which could, in the opinion of the investigator, affect compliance with the study treatment and procedures\n* Close affiliation with the investigational site, investigators or staff\n* Simultaneous participation in another interventional trial within 30 days prior to randomization",{"count":124,"type":21},100,[126],"PHASE2","EFFEKTOR is a vanguard, multicenter, phase 2 randomized, double blinded, placebo controlled clinical trial to determine the feasibility, tolerability, safety, and efficacy of finerenone in kidney transplant recipients (KTRs). One hundred fifty (150) KTRs will be randomized in a 2:1 ratio of finerenone to placebo, with two embedded substudies: (i) a kidney biopsy substudy in 50 participants who undergo a research kidney biopsy prior to randomization and at the end of active treatment; and (ii) a functional MRI (fMRI) substudy in 50 participants who undergo fMRI prior to randomization and at the end of active treatment.",[27],[130,131,132,133,134,135,136],"Finerenone","Cardiovascular Outcomes","Albuminuria","eGFR decline","Congestive Heart Failure","Kidney biopsy","Functional MRI","2026-04-09",{"date":139,"type":35},"2026-04-14",{"date":141,"type":35},"2024-04-23",{"date":143,"type":21},"2027-12-31",{"name":145,"class":42},"University of North Carolina, Chapel Hill",{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":52,"phases":156,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100577485","phase-3-kidney-transplant-preemptive-therapy-or-prophylaxis-for-cmv-prevention-in-dr-recipients-100577485","NCT06798909","Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients","Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients","KPoP","Inclusion Criteria:\n\n1. Subject or legally authorized representative has provided written informed consent.\n2. Age ≥ 18 years of age at the time of informed consent.\n3. Negative for IgG antibody to CMV as assessed in a CLIA-certified laboratory between 28 days prior to transplant and up to 7 days post-transplant but prior to randomization.\n4. Received a kidney transplant from a CMV seropositive (IgG positive) donor in the past 7 days prior to enrollment\n5. Individuals of reproductive (childbearing) potential must have a negative pregnancy test (serum or urine) collected prior to randomization (SOC results within 7 days prior to transplant may be used), and must also agree to use a medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence from the time of enrollment through until discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.\n\n   NOTE: Individuals of reproductive potential are defined as individuals who have reached menarche and who have not been post-menopausal for at least 12 consecutive months with follicle stimulating hormone (FSH) ≥40 IU\u002FmL or 24 consecutive months if an FSH is not available, i.e., who have had menses within the preceding 24 months, and have not undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, or salpingectomy).\n6. If male, must agree to practice a barrier method of contraception or abstinence from the time of enrollment through 3 months after discontinuation of ganciclovir or valganciclovir in either arm during the intervention period.\n\nExclusion Criteria:\n\n1. In the opinion of the investigator, participants who are unable or unwilling to undergo preemptive therapy protocol (weekly CMV PCR, etc.)\n2. Patients who are breastfeeding or planning to breastfeed within 6 months post-transplant\n3. Allergy to valganciclovir\u002Fganciclovir or Letermovir\n4. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes COVID convalescent plasma)\n5. Currently enrolled or anticipated enrollment in another interventional study that, in the opinion of scientific leadership team, could affect evaluation of the primary safety and\u002For efficacy outcomes.\n6. Most recent platelet count post-transplant \\\u003C25,000\u002FuL\n7. Most recent ANC performed post-transplant \\\u003C1000\u002FuL\n8. Multi-organ transplant (except simultaneous kidney-pancreas) within the past 7 days\n9. Prior or planned receipt of a hematopoietic cell transplant\n10. Baseline immunodeficiency prior to transplant, including but not limited to:\n\n    1. Known or suspected HIV infection\n    2. Congenital or acquired immunodeficiency\n11. Unacceptable immunosuppression\n\n    1. Receipt of desensitization therapy prior to kidney transplant, or\n    2. Receipt of an ABO-incompatible kidney transplant except A2 to blood type B",{"count":155,"type":21},360,[157],"PHASE3","This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily \\[both dose adjusted per Food and Drug Administration (FDA) label\\] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study.\n\nEstimated Time to Complete Enrollment: 4 years",[160,27,161],"Cytomegalovirus (CMV)","Kidney Diseases","2026-03-26",{"date":164,"type":35},"2026-04-01",{"date":166,"type":35},"2025-07-22",{"date":168,"type":21},"2031-05-31",{"name":170,"class":42},"University of California, San Francisco",5,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100534098","cardiovascular-risk-assessment-for-kidney-transplantation---utility-of-computed-tomography-coronary-angiography-in-the-assessment-of-patients-awaiting-kidney-transplantation-100534098","NCT06234410","Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation","CRAFT-CTCA","Inclusion Criteria:\n\n* Has kidney failure and is on the waitlist for a kidney transplant\n* Age 16 years and over\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Contraindication to CT scanning, including contrast allergy\n* Patients being considered for a simultaneous kidney-pancreas, kidney-liver and\u002For kidney-islet transplantation\n* Inability to give informed consent","16 Years",{"count":181,"type":21},332,"Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.\n\nCurrent strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes.\n\nThis study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function.\n\nThe aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation.",[184,27],"Cardiovascular Diseases",[186,187,188,189,190],"Coronary artery disease","Kidney transplantation","Cardiovascular risk assessment","Heart disease","Chronic kidney disease","2026-02-12",{"date":193,"type":35},"2026-02-13",{"date":195,"type":35},"2024-01-24",{"date":197,"type":21},"2032-01",{"name":199,"class":42},"University of Edinburgh",2,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":52,"phases":212,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100599387","phase-1-ecp-dl-cell-infusion-for-induction-in-living-donor-kidney-ldk-transplants-100599387","NCT07083830","ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants","A Phase I, Single Center Trial of Donor Extracorporeal Photopheresis (ECP) Treated Cell Infusion (ECP-DL) Plus Post-transplant ECP for the Prevention of Rejection in Living Donor Kidney Transplant Recipients","ECP","Inclusion Criteria:\n\n* Recipient age ≥30 and less than 70 years old.\n* Donor age ≥18 and ≤ 70 years old.\n* Recipient of a first kidney transplant from a living unrelated or living related donor that is not HLA-identical to the donor.\n* Donor willing to undergo cell collection for ECP-DL cell preparation and infusion.\n* Donors will be screened and tested for HIV-1 (antigen and nucleic acid), HIV-2, hepatitis B virus (HBV, nucleic acid and surface and core antigen), hepatitis C virus (HCV, antigen and nucleic acid), Treponema pallidum (syphilis), West Nile Virus (WNV), and CJD (screening only). and tested for human T-lymphotropic virus types 1 and 2 (HTLV-1, HTLV-2) and CMV, in accordance with established UNOS guidelines for solid organ donors.\n* Donors and recipients who test negative for TB using QuantiFERON gold assay.\n* Must be willing and able to comply with protocol-required visit schedule and visit requirement.\n* Patients who are single-organ recipients (kidney only).\n* Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period. Both male and female transplant recipients must agree to the use of highly effective birth control for 12 months following ECP-DL procedure. Individuals unwilling to do so will be excluded from study participation.\n* Subjects are able to understand the consent form and give written informed consent.\n\nExclusion Criteria:\n\nRECIPIENT\n\n* Known sensitivity or contraindication to everolimus, tacrolimus, or psoralen.\n* Aphakia.\n* Has undergone splenectomy\n* Patients with light-sensitive diseases including (but not limited to) systemic lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porhyria, xeroderma pigmentosum, and albinism\n* Patient with significant or active infection.\n* Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.\n* Patients with PRA \\>80%\n* Patients with current or historic donor specific antibodies\n* Body Mass Index (BMI) of \\\u003C 18 or \\> 40\n* Patients who are pregnant or nursing mothers\n* Patients whose life expectancy is severely limited by diseases other than renal disease\n* Ongoing active substance abuse, drug or alcohol\n* Major ongoing psychiatric illness or recent history of noncompliance\n* Significant cardiovascular disease\n* Malignancy within 3 years, excluding nonmelanoma skin cancers\n* Subjects with cerebrovascular vascular disease with recent (\\\u003C 6 months) stroke\n* Serologic evidence of infection with HIV or HBVs Ag positive\n* Recipient is EBV serologic negative\n* Donor CMV serologic positive to recipient CMV serologic negative\n* Recipient tests positive for HCV viral load by PCR\n* Patients with a screening\u002Fbaseline total white blood cell count \\\u003C 4,000\u002Fmm3; platelet count \\\u003C 100,000\u002Fmm3; triglyceride \\> 400 mg\u002Fdl; total cholesterol \\> 300 mg\u002Fdl\n* Investigational drug within 30 days prior to transplant surgery\n* Anti-T cell therapy within 30 days prior to transplant surgery\n* Documented severe liver disease, defined as bridging fibrosis or cirrhosis on liver biopsy\n* Poorly controlled diabetes, defined as HbA1c of \\> 8.0\n* PT\u002FINR \\> 2.0\n* SBP \\\u003C 90 or \\> 180mm Hg, HR \\> 120 or \\\u003C50bpm, Temp \\> 99.5F on day of proposed ECP-DL procedure\n* Patients receiving concomitant enteral or topical medical therapy with potentially photosensitizing effects\n\nDONOR\n\n* Lack of possible peripheral IV access (two access sites)\n* Has undergone splenectomy\n* Donor tests positive for HCV viral load by PCR\n* PT\u002FINR \\> 2.0; or known hyper or hypo coagulable disorders\n* Hgb \\\u003C 10.0\n* platelet count \\\u003C 100,000\n* SBP \\\u003C 90 or \\> 160mm Hg, HR \\> 120 or \\\u003C50bpm, Temp \\> 99.5F on day of proposed ECP-DL procedure\n* Donors who cannot tolerate extracorporeal volume during PBMC collection","70 Years",{"count":211,"type":21},24,[213],"PHASE1","This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients. 2) Determine rates of graft rejection and compare to historical controls.\n\nOne week prior to planned LDK transplant the donor and recipient pair will be seen for ECP-DL preparation and infusion. Donors will undergo one single unstimulated peripheral blood mononuclear cell collection using the THERAKOS® CELLEX® Photopheresis System; the cell product will then undergo ECP treatment to make ECP-DL, which will then be infused into the recipient. One week later, recipients (n=12) will undergo LDK transplant using standard of care maintenance immunosuppression without antibody induction therapy. Subsequent patients will receive cell infusions in escalating cell doses. A minimum of two months will be used as an interval between ECP-DL treatment in each tier. A staggered approach for moving to the next tier will be employed waiting no less than two months to ensure absence of adverse events using the following tier dosing schema:\n\nTier 1: 0.5 x 10\\^9 ECP-DL treated cells (n=4) Tier 2: 1 x 10\\^9 ECP-DL treated cells (n=4) Tier 3: 2 x 10\\^9 ECP-DL treated cells (n=4)\n\nFollowing transplant, LDK recipients will undergo ECP using the Therakos system on two consecutive days per month for 6 months (12 treatments). Peripheral IV access will be used whenever possible.",[216,27],"Kidney Transplant Failure and Rejection","NOT_YET_RECRUITING","2026-02-06",{"date":220,"type":35},"2026-02-10",{"date":222,"type":21},"2026-03-30",{"date":224,"type":21},"2028-08-25",{"name":226,"class":42},"Northwestern University",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":52,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":43},"100422639","use-of-cgm-in-kidney-transplant-recipients-100422639","NCT04783441","Use of CGM in Kidney Transplant Recipients","Continuous Glucose Monitoring (CGM) to Improve Glycemic Control in Kidney Transplant Recipients","Inclusion Criteria:\n\n1. Age 18 or above\n2. Received a kidney transplant within the past year with functioning kidney (eGFR \\> 30 mL\u002Fmin\n3. Person with Type 2 Diabetes and on insulin\n4. Access to home wi-fi connection\n\nExclusion Criteria:\n\n1. Person with Type 1 Diabetes\n2. Patients taking hydroxyurea\n3. Patient unable to wear the Dexcom G6 device at all times for any reason\n4. Must be able to test blood glucose with meter 4x a day when on blinded CGM.\n5. Presence of clinically significant visual or cognitive impairment\n6. Illiterate\n7. Prisoners\n8. Women who are pregnant, who plan to become pregnant during the course of the study, or who are breastfeeding\n9. Presence of clinically unstable cardiovascular disease\n10. Active malignancy treatment",{"count":235,"type":21},80,[54],"The investigators want to study the impact CGM (continuous glucose monitoring) has on patients glycemic control as determined by time in range (TIR 70-180 mg\u002FdL) in the Diabetic Kidney Transplant population.",[27,239,240],"Diabetes Mellitus, Type 2","Insulin Dependent Diabetes","2026-01-27",{"date":243,"type":35},"2026-01-29",{"date":245,"type":35},"2021-06-29",{"date":247,"type":21},"2026-12-31",{"name":249,"class":42},"University of California, Davis",{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":52,"phases":260,"briefSummary":262,"conditions":263,"keywords":268,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":200},"100589775","phase-4-strategic-help-with-immunoglobulin-to-enhance-protect-against-late-disease-cmv-100589775","NCT06958796","Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)","Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection","SHIELD","Inclusion Criteria\n\n* High risk pretransplant CMV donor seropositive\u002Frecipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients\n* Able to do routine blood testing (normal care for transplant recipients)\n* Written informed consent obtained from the subject before any trial-related procedures\n* Be ≥18 years and ≤75 years of age at time of consent\n\nExclusion Criteria\n\n* Any pre-transplant CMV serologic combinations besides CMV D+\u002FR-\n* Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant\n* Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients\n* Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis\n* Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent\n* Transplant recipients with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 (as they theoretically could be at higher risk for renal impairment with CMV immunoglobulin), poor transplant organ function (i.e. LFTs \\> twice the upper limit of normal in liver recipients), or who are on dialysis, or plasmapheresis, or who are relisted for transplant, or who might otherwise at risk of complications at the discretion of the local site investigator.\n* Those with a history of severe reaction to CMV immunoglobulin (e.g. CytoGam® or similar) or other human immunoglobulin preparations\n* Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)\n* Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening\n* History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \\[e.g., severe pulmonary hypertension (WHO class IV)\\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions\n* Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)\n* Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n* Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or \"tubes tied\"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.\n* Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk\n* Subjects who have any of the following laboratory values: eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 ; Hemoglobin \\\u003C8.0 g\u002FdL; Platelets \\\u003C50,000 cells\u002FuL; Absolute neutrophil count \\\u003C1,000 cells\u002FuL; Total bilirubin \\>2.5 x upper limit of normal; Alanine aminotransferase (ALT) \\>5 x upper limit of normal; Aspartate aminotransferase (AST)\\] \\>5 x upper limit of normal; CMV IgG negative in donor or positive in recipient","75 Years",{"count":235,"type":21},[261],"PHASE4","This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and\u002For kidney transplant.",[264,265,27,266,267],"Cytomegalovirus","Organ Transplant","Liver Transplant Complications","Simultaneous Liver-Kidney Transplantation; Complications",[269,270,271,272,273,274],"cytomegalovirus","valganciclovir","organ transplant","immunoglobulin","CMV","High Risk CMV","2025-12-18",{"date":277,"type":35},"2025-12-22",{"date":279,"type":35},"2025-11-27",{"date":281,"type":21},"2028-05-31",{"name":283,"class":42},"Camille N. Kotton, MD",{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":12,"sex":17,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":52,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":95},"100499383","renal-ex-vivo-warm-advanced-resuscitation-through-machine-perfusion-100499383","NCT05782543","Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion","Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion - The REWARM Study","REWARM","Inclusion Criteria:\n\n* Patients receiving their first or second kidney transplant;\n* Patients receiving a graft from a ≥ 50-year-old donor;\n* Patients receiving a graft from a DCD or DBD donor;\n* Patients receiving a kidney transplant in the UMCG, the Erasmus MC, or the LUMC;\n* Patients receiving a graft stored on HMP;\n* Patients ≥ 18 years of age;\n* Patients having provided written informed consent.\n\nExclusion Criteria:\n\n* Patients receiving their third or subsequent kidney transplant;\n* Patients receiving a graft from a donor \\\u003C 50 years;\n* Patients receiving a graft not stored on HMP;\n* Patients receiving a graft from a donor that underwent normothermic regional perfusion (NRP);\n* Patients receiving a kidney transplant in another center than the UMCG, Erasmus MC, or LUMC;\n* Patients receiving a multi-organ transplantation;\n* Patients receiving a kidney with complex arterial anatomy (3 or more arteries);\n* Recipients \\\u003C 18 years of age.","50 Years","100 Years",{"count":295,"type":21},240,[54],"The REWARM study is a randomized controlled clinical efficacy study, with primary outcome renal function 12 months after transplantation of kidneys recovered from deceased donors aged 50 years or older. Prior to transplantation, kidney grafts in the intervention group will receive 6 hours of NMP, following standard HMP and kidneys in the control group will only receive standard treatment, being HMP. It is a multi-center trial. Given the total annual 50+ deceased donor kidney transplantation volume of the three participating transplant centers combined, inclusions in the study are expected to last 2.5-3 years, aiming for a total of 120 patients in each of the two arms (240 patients total).",[27],"2025-12-10",{"date":275,"type":35},{"date":302,"type":35},"2024-12-15",{"date":304,"type":21},"2028-05-01",{"name":306,"class":42},"University Medical Center Groningen",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":314,"targetDuration":4,"studyType":52,"phases":315,"briefSummary":316,"conditions":317,"keywords":318,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":43},"100600358","phase-1-cmvig-prophylaxis-in-belatacept-conversion-kidney-transplant-recipients-100600358","NCT07096453","CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients","CMVIG Prophylaxis in Belatacept Conversion Kidney Transplant Recipients: a PK Pilot Study","Inclusion Criteria:\n\n* Adult (18-70 year old) kidney transplant recipients\n* Patients transitioning from conventional CNI-based immunosuppression to co-stimulatory blockade (belatacept) immunosuppression OR patients who are stable on belatacept immunosuppression at the time of initial CYTOGAM infusion\n* CMV Ig Seronegative Recipient who received a CMV Ig seropositive Donor\n* EBV IgG Positive\n\nExclusion Criteria:\n\n* Pregnant people\n* Subjects unwilling to sign consent and complete follow up visits\n* Subjects with IgA immunodeficiency\n* Subjects who are receiving IgG therapy or who have received IgG therapy within two months of study enrollment\n* Patients who do not speak English and would need a translator and translated consent materials in order to obtain informed consent",{"count":51,"type":21},[213,126],"The purpose of this study is to study how CMVIG interacts with the body and to see if it might work to prevent kidney transplant patients from becoming infected with CMV.",[27,273],[319,320],"Kidney transplant","CMV prevention","2025-10-29",{"date":323,"type":35},"2025-10-31",{"date":325,"type":35},"2025-10-02",{"date":327,"type":21},"2027-08",{"name":329,"class":42},"University of Minnesota",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":43},"100526077","mr-proadm-as-a-early-biomarker-for-dgf-and-ar-in-kidney-and-liver-transplantation-100526077","NCT06130046","MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation","DARE","Inclusion Criteria:\n\n* Kidney transplant recipient at our Institution\n* Liver transplant recipient at our Institution\n\nExclusion Criteria:\n\n* Re-transplantation\n* Dual kidney transplantation\n* Combined transplant (kidney-liver, kidney-pancreas)\n* Autoimmune disease as indication to transplant",{"count":338,"type":21},300,"To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM and by a machine learning process.",[27,341],"Liver Transplant; Complications",[343,344,345,346,347,348],"MR-proADM","Adrenomedullin","Kidney Transplantation","Liver Transplantation","DGF","Acute rejection","2025-07-29",{"date":351,"type":35},"2025-08-01",{"date":353,"type":35},"2022-12-01",{"date":355,"type":21},"2026-12-01",{"name":357,"class":42},"University of Rome Tor Vergata",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":258,"enrollmentInfo":365,"targetDuration":367,"studyType":23,"phases":4,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":200},"100540237","australian-genomics-of-chronic-allograft-dysfunction-study-100540237","NCT06314230","Australian Genomics Of Chronic Allograft Dysfunction Study","AUSCAD","Inclusion Criteria:\n\n* Living or deceased donor kidney transplant candidate.\n* Biological sex: any\n* Ages: 18-75 years.\n* Subject must be able to understand and provide informed consent.\n* Deceased donor individuals where Research Consent has been obtained from the person consenting to organ donation at the time of organ retrieval.\n* Identifiable living donors who have received informed consent and have consented to participate in the project.\n\nExclusion Criteria:\n\n* Presensitization in living donor recipients prior to transplantation, as determined by site-specific standards, OR positive cross match according to site specific technique in cadaveric donor recipients.\n* Recipients of multiple organ transplants, with the exception of kidney\u002Fpancreas transplants.\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* High risk populations including pregnant women, children less than 18 years and prisoners will not be included in the study.\n* Non English speaking potential participants who do not understand the requirements of the study will not be included.",{"count":366,"type":21},500,"2 Years","The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles.",[370,27],"Kidney Transplant Rejection","2025-07-14",{"date":373,"type":35},"2025-07-17",{"date":375,"type":35},"2012-04-26",{"date":377,"type":21},"2040-01-01",{"name":379,"class":42},"Western Sydney Local Health District",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":52,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":43},"100595546","evaluaion-the-short-term-effects-of-advograf-plus-rapamiune-after-kidney-transplantation-100595546","NCT07033858","Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation","Investigating the Effect of Low-dose Extended-release Tacrolimus and Sirolimus on the Short-term Outcomes of Allograft Kidney Transplantation","Inclusion Criteria:\n\n* All Kidney transplant recipients\n\nExclusion Criteria:\n\n* Kidney-Pancreas transplant BMI\\>30 cPRA\\>0%",{"count":388,"type":21},50,[54],"Cornerstone immunosuppressive therapy currently relies on immediate-release tacrolimus, a calcineurin inhibitor (CNI) that is potentially nephrotoxic and is more diabetogenic than cyclosporine A. A new formulation of tacrolimus has been launched: an extended-release formulation (Advagraf®\u002FAstagraf XL®, Astellas company).",[27],"2025-06-14",{"date":394,"type":35},"2025-06-24",{"date":396,"type":35},"2025-03-01",{"date":398,"type":21},"2026-07-01",{"name":400,"class":42},"Shahid Beheshti University of Medical Sciences",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":52,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":43},"100526883","phase-4-efficacy-and-mechanisms-of-dapagliflozin-in-promoting-kidney-function-and-cardiovascular-health-in-kidney-transplant-recipients-100526883","NCT06140537","Efficacy and Mechanisms of Dapagliflozin in Promoting Kidney Function and Cardiovascular Health in Kidney Transplant Recipients","Inclusion Criteria:\n\n* Age 18-80 years\n* Kidney transplant received 1 year prior to randomization\n* estimated glomerular filtration rate 30-90 ml\u002Fmin\u002F1.73m2\n* Urine albumin to creatinine ratio (ACR) 30-5000 mg\u002Fg\n* Pre-existing type 2 diabetes or post-transplant diabetes mellitus\n* Blood pressure \\\u003C130\u002F80 mm Hg prior to randomization\n* Able to provide informed consent\n* Stable immunosuppression for at least 3 months prior to baseline consisting of tacrolimus, mycophenolate mofetil\u002Fmycophenolic acid and prednisone\n* Stable anti-hypertensive regimen for at least 1month prior to baseline\n* Stable diabetes management for at least 3 months prior to baseline\n* Stable angiotensin converting enzyme inhibitor\u002Fangiotensin receptor blocker use for at least 3 months prior to baseline (if applicable)\n* Glucagon-like peptide-1 receptor agonist (GLP-1RA) for at least 3 months prior to baseline (if applicable)\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Anticipated life expectancy \\\u003C1 year\n* Uncontrolled hypertension\n* Hemoglobin A1c \\>9%\n* Body mass index \\>40 kg\u002Fm2\n* New York Heart Association Class 3 or 4 heart failure symptoms, an EF ≤30%, or hospitalization for heart failure in the past 3 months\n* Pregnancy, plans to become pregnant, or breastfeeding\n* Current use of sodium glucose cotransporter-2 (SGLT2) inhibitors\n* Current urinary or urogenital infection\n* Use of anticoagulants (contraindication to kidney biopsy)\n* Magnetic resonance imaging (MRI) contraindications\n* History of lower-limb amputation irrespective of etiology\n* Known hypersensitivity to dapagliflozin","80 Years",{"count":235,"type":21},[261],"Long-term allograft function in kidney transplant recipients (KTRs) remain suboptimal, and graft failure causes significant morbidity and mortality, with cardiovascular disease being the leading cause of death in KTRs and the most common cause of death with a functioning graft. Sodium-glucose cotransporter 2 (SGLT2) inhibitors safely lower cardiovascular and kidney disease risk in the non-transplant population, yet data in KTRs are lacking. This clinical trial seeks to establish the efficacy and safety of dapagliflozin, a SGLT2 inhibitor, for improving cardiovascular and kidney graft function in adult KTRs with type 2 diabetes and post-transplant diabetes, and to leverage innovate translational methods to define the underlying mechanisms of action.",[27,412,413],"Vascular Diseases","Diabetes","2025-05-28",{"date":416,"type":35},"2025-05-29",{"date":418,"type":35},"2024-02-01",{"date":420,"type":21},"2028-12-31",{"name":422,"class":42},"University of Colorado, Denver",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":407,"enrollmentInfo":430,"targetDuration":4,"studyType":52,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":43},"100439707","phase-4-effect-of-alkali-therapy-on-vascular-and-graft-function-in-kidney-transplant-recipients-100439707","NCT05005793","Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients","Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant","Inclusion Criteria:\n\n* Age 18-80 years\n* Serum bicarbonate 16-24 mEq\u002FL on 2 separate measurements (at least 1 day apart)\n* Kidney transplant received 1 year prior to randomization\n* eGFR ≥ 45 ml\u002Fmin\u002F1.73m2 by CKD-EPI equation\n* Blood pressure \\\u003C130\u002F80 mm Hg prior to randomization\n* BMI \\\u003C 40 kg\u002Fm2 (FMD measurements can be inaccurate in severely obese patients).\n* Able to provide consent\n* Immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at University of Colorado are on this regimen)\n* Stable immunosuppression regimen for at least three months prior to randomization\n* Stable anti-hypertensive regimen for at least one month prior to randomization\n* Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).\n\nExclusion Criteria:\n\n* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year\n* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)\n* Uncontrolled hypertension\n* Serum potassium \\\u003C 3.3 or ≥ 5.5 mEq\u002FL at screening\n* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months\n* Nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria)\n* Factors judged to limit adherence to interventions\n* Current participation in another research study\n* Pregnancy or planning to become pregnant or currently breastfeeding\n* Chronic use of supplemental oxygen\n* Use of anticoagulants",{"count":431,"type":21},120,[261],"Lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (KTRs) are associated with an increased risk of graft loss, cardiovascular events and mortality. Because acid retention is common in KTRs, it is plausible that alkali therapy in KTRs may also result in improved vascular and graft function. The investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 KTRs to examine the effect of sodium bicarbonate therapy on surrogate markers of CVD and graft function. The overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in KTRs by decreasing complement activation.",[435,27,412],"Metabolic Acidosis",{"date":416,"type":35},{"date":438,"type":35},"2021-12-01",{"date":440,"type":21},"2026-08-31",{"name":422,"class":42},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":52,"phases":450,"briefSummary":451,"conditions":452,"keywords":453,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":43},"100416388","added-value-of-18-fdg-pet-scanner-in-diagnosis-and-management-of-subclinical-rejection-in-kidney-transplant-patients-100416388","NCT04702022","Added Value of 18 FDG Pet-scanner in Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients","Non-invasive Diagnosis and Management of Subclinical Rejection in Kidney Transplant Patients Using 18F-fluorodeoxy Glucose Positron Emission Tomography (18FDG-PET\u002FCT)","Inclusion Criteria:\n\n* Kidney recipients aged over 18 and of all sexes\n\nExclusion Criteria:\n\n* Pregnant patients\n* Polyomavirus nephropathy\n* Highly sensitised patients (historical or at 3 months Donor specific antibodies)\n* No corticosteroids withdrawal allowed (second kidney transplantation or primary disease)",{"count":388,"type":21},[54],"The renal biopsy (RB) represents the gold-standard for the diagnosis of acute renal transplant rejection (AR), and allows early verification of a so-called \"subclinical\" rejection, ie without any clinical or biological abnormality detectable in a stable kidney transplant patient. The RB also makes it possible to certify a strictly normal renal histology and thus to motivate the withdrawal of corticosteroid therapy. It is this 3-month post-transplant protocol RB protocol that has been effective since 2007 at the CHU Liège.\n\nHowever, RB is an invasive procedure, contraindicated in patients taking anticoagulants, and carrying a significant risk of complications. The potential complications associated with RB motivate the identification and validation of other diagnostic means. In the present project, the investigators propose to study the relevance of positron emission tomography (PET), coupled with conventional tomography (CT), after intravenous injection of 18-fluoro-deoxy-glucose (18FDG) in the overall protocol of the renal transplant patient at 3 months post-transplant to:\n\n(i) allow protocol renal biopsy only in patients with suspicion of an acute rejection (ii) be a decision maker for withdrawal from corticosteroids in the absence of rejection\n\nIn practice, the investigators suggest performing 18FDG PET \u002F CT imaging on the day of the surveillance biopsy, which is systematically performed in all kidney transplant patients at University Hospital of Liège 3 months after transplant. The investigators are considering 3 scenarios:\n\n* Scenario 1. The renal biopsy shows signs of humoral rejection: the patient is excluded from the study and is treated \"as usual\" on the basis of the histological results.\n* Scenario 2. The renal biopsy does not show signs of humoral rejection but the 18FDG PET \u002F CT shows a high metabolic activity of the graft (\\> 2.4): the patient is treated \"as usual\" on the basis of histological findings.\n* Scenario 3. The renal biopsy does not show signs of humoral rejection and the 18FDG PET \u002F CT shows a weak metabolic activity of the graft (\\\u003C2.4): the immunosuppressive treatment is gradually weaned off corticosteroids.\n\nThis clinical research project is interested in a major health problem in the follow-up of renal transplant patients, and could make it possible to improve the management of a subclinical rejection of the renal transplant and to increase the withdrawal of corticosteroids including side effects are well known.",[370,27],[454,455,456],"PET\u002FCT imaging","Corticoids withdrawal","SubClinical Rejection","2025-04-06",{"date":459,"type":35},"2025-04-09",{"date":461,"type":35},"2021-01-04",{"date":463,"type":21},"2027-01-01",{"name":465,"class":42},"University of Liege",{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":473,"maxAge":258,"enrollmentInfo":474,"targetDuration":4,"studyType":52,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":4},"100560848","phase-2-a-trial-to-assess-efficacy-and-safety-of-ex-vivo-allograft-admin-of-icm012-solution-2-mgml-to-improve-its-function-in-recipients-of-dcd-kidneys-100560848","NCT06582485","A Trial to Assess Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg\u002Fml to Improve Its Function in Recipients of DCD Kidneys","A Randomized, Placebo-controlled, Double-blind Phase 2b Trial to Assess the Efficacy and Safety of ex Vivo Allograft Admin of iCM012 Solution 2 mg\u002FmL to Improve Allograft Function in Recipients of Donation After Circulatory Death Kidneys","Inclusion Criteria:\n\nTo be eligible for use in this trial, an allograft must meet the following criterion:\n\n1. Controlled DCD donors Maastricht category III from 55 to 75 years of age.\n\n   To be eligible to participate in this trial, a patient must meet all the following criteria:\n2. Available, personally signed and dated Informed Consent Form.\n3. Male or female chronic kidney disease (CKD) ≥ 18 years of age, on dialysis \\> 12 months, awaiting their first kidney transplantation.\n4. AB0-compatible, negative pre-transplantation Complement Dependent Cytotoxicity (CDC) and\u002For flow cytometric class I and II crossmatch, or negative virtual class I and II crossmatch, and no pre-existing donor specific antibodies (Mean Fluorescent Intensity under center specific cut-off for negative value).\n5. Completed vaccination program according to local standard practice or as deemed relevant by the investigator.\n\nExclusion Criteria:\n\nAn allograft that meets any of the following criteria will be excluded from use in this trial:\n\n1. Surgically induced injuries or anatomical vascular variations compromising ex vivo treatment and\u002For transplantation outcome, as judged by the investigator.\n2. DCDs with persistent and significant deterioration of kidney function (30% decrease in eGFR from baseline) and\u002For on dialysis within two (2) weeks prior to organ procurement and\u002For anuria \\> 12 hours before surgery.\n3. Extracorporeal membrane oxygenation treatment of the donor\n\n   A patient who meets any of the following criteria will be excluded from participation in this trial:\n4. If not tolerating\u002Feligible for thymoglobulin induction and tacrolimus or Cyclosporine A (CyA)-based maintenance immunosuppressants.\n5. Previously undergone any organ and\u002For cell transplantations.\n6. Positive CDC and or flow cytometric class I and\u002For II crossmatch, and\u002For positive virtual crossmatch.\n7. Highly sensitized patients defined by Panel Reactive Antibody (PRA) level equal or higher than 98%.\n8. AB0-incompatible deceased donor kidney transplantation.\n9. Pregnant or breast-feeding woman.\n10. Woman of child-bearing potential, not using an adequate contraceptive method.\n11. Prior participation in a clinical trial with (approved or non-approved) IMPs within 1 month prior to screening for this trial.\n12. Prior malignancy diagnosis ≤ 5 years, except for adequately treated basal cell, or squamous cell skin cancer, and carcinoma in situ, or judged as irrelevant by the investigator.\n13. Positive result for serum human immunodeficiency virus (HIV), active hepatitis B or C infection in pre-transplantation evaluation.\n14. History of severe drug allergy or hypersensitivity, or known hypersensitivity, or intolerance to any of the IMPs or its\u002Ftheir excipients.\n15. Concomitant severe conditions requiring treatment and close monitoring, as judged by the investigator.\n16. History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the trial, or influence the results or the patient's ability to participate in the trial.\n17. Unlikely to comply with trial procedures, restrictions, and requirements (e.g., caused by substance abuse, concurrent medical condition, etc.), as judged by the investigator.","55 Years",{"count":475,"type":21},200,[126,157],"Randomized (1:1), placebo controlled, double blind efficacy trial. 200 patients will be followed up for 12 months post transplantation. The primary endpoint will be Delayed Graft Function (DGF) defined as the requirement for dialysis within 7 days post transplantation.",[479,27],"Ischemia-reperfusion Injury",[481,482,483,479],"Ex-vivo kidney allograft treatment","kidney transplantation","Transplant outcome","2025-03-31",{"date":486,"type":35},"2025-04-03",{"date":488,"type":21},"2025-09",{"date":490,"type":21},"2026-12",{"name":492,"class":493},"iCoat Medical AB","INDUSTRY",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":258,"enrollmentInfo":501,"targetDuration":4,"studyType":52,"phases":503,"briefSummary":504,"conditions":505,"keywords":508,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":43},"100499824","phase-4-can-dapagliflozin-preserve-structure-and-function-in-transplanted-kidneys-100499824","NCT05788276","Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?","DEAKTransplant","Inclusion Criteria:\n\n* Renal transplant recipients transplanted 6 weeks earlier at Oslo University hospital (OUH) Rikshospitalet.\n* Age 18-75 years.\n* Able to comply with the medical treatment on their own.\n* Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks.\n* Estimated GFR ≥25 mL\u002Fmin\u002F1.73 m2.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Rejection episodes of the kidney graft prior to randomization.\n* Ongoing infectious disease or intermittent causes affecting renal function, e.g., obstructive lymphocele.\n* Malnutrition.\n* Urosepsis less than 1 year prior to randomization.\n* Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.\n* For women only - currently pregnant",{"count":502,"type":21},330,[261],"The goal of this clinical trial is to look at the effect of SGLT2 (Sodium glucose transporter 2) inhibition in patients receiving a kidney-transplant 6 weeks earlier at Oslo University hospital. Rikshospitalet. Investigators will search for answers along three pathways: Can SGLT2 inhibitor 1) preserve glomerular filtration rate (GFR), 2) reduce interstitial fibrosis in the kidney, and 3) favorably improve metabolic risk factors for graft failure such as visceral obesity, glucose intolerance and high blood pressure? The participants (N=330) will be randomized to either dapagliflozin 10 mg or placebo o.d. in a blinded fashion. Researchers will than use kidney transplant biopsies, measured GFR, blood pressure sampling, glucose tolerance test (OGTT), dual-energy X-ray absorptiometry (DXA scan) and estimated GFR from the two groups in comparison, to evaluate the effect treatment. The participants will be followed for a total of 3 years.",[27,506,507],"Kidney Transplant Failure","Renal Failure",[509,510,511,512],"Kidney","Transplantation","SGLT2","Renal function","2025-03-26",{"date":515,"type":35},"2025-04-01",{"date":517,"type":35},"2023-05-02",{"date":519,"type":21},"2028-06",{"name":521,"class":42},"Oslo University Hospital",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":43},"100417291","bone-density-and-vascular-calcifications-evolution-after-renal-transplant-100417291","NCT04713774","Bone Density and Vascular Calcifications Evolution After Renal Transplant","Evolution of Bone Density, Bone Micro-architecture and Vascular Calcifications in Patients After Kidney Transplantation","Inclusion Criteria:\n\n* At least 18 years old\n* Recent kidney transplant patients (\\\u003C3 months)\n* Medical history available\n* Biological parameters of the past year available\n\nExclusion Criteria:\n\n* Treatment with bisphosphonate, RANKL inhibitor or SERM with bone action in the last 3 months before the transplant\n* Multiple organ transplant patients",{"count":388,"type":21},"The investigators project is based on:\n\n* Assessment of bone architecture by high resolution peripheral scanner (HRpQCT) and bone densitometry (DEXA);\n* The non-invasive detection of vascular calcifications (by abdominal CT scanner) and bone abnormalities associated with kidney transplantation, as well as the analysis of evolution over time;\n* Longitudinal evaluation of nephrological clinical parameters (glomerular filtration rate, number and type of rejections, immunosuppressive medications) as well as biological and urinary parameters of mineral metabolism (parathormone, sclerostin, bone alkaline phosphatase) depending on the type and severity of bone abnormalities;\n* The evaluation of these nephrological clinical parameters and of the biological parameters of mineral metabolism depending on the extent and evolution of vascular calcifications but also on bone morphology;\n* The study of possible relationships between bone mass and muscle mass (and functioning)",[27,532],"Bone Loss","2024-12-13",{"date":535,"type":35},"2024-12-18",{"date":537,"type":35},"2020-09-01",{"date":539,"type":21},"2026-12-13",{"name":465,"class":42},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":549,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":52,"phases":551,"briefSummary":552,"conditions":553,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":43},"100523423","effect-of-empagliflozin-vs-linagliptin-on-glycemic-outcomesrenal-outcomes--body-composition-in-renal-transplant-recipients-with-diabetes-mellitus-100523423","NCT06095492","Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus","Effect of Empagliflozin Versus Linagliptin on Glycemic Outcomes, Renal Outcomes and Body Composition in Renal Transplant Recipients With Diabetes Mellitus: Randomized Controlled Trial (EmLina Renal Trial)","EmLinaRenal","Inclusion Criteria:\n\n1. A man or woman, 30 years of age or above with the diagnosis of diabetes mellitus (pre-transplantation type 2 diabetes or post-transplantation diabetes mellitus) and after at least 3 months of renal transplantation.\n2. Patients must have stable renal function (less than 20% deviation in serum creatinine in last one month: eGFR \\>30 ml\u002Fmin\u002F1.73 m2)\n3. Patients must be on a stable immunotherapy for last one month.\n4. Subjects must be medically stable on the basis of medical history, physical examination and laboratory investigations.\n5. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n6. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.\n2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.\n3. BMI \\\u003C=18 kg\u002Fm2\n4. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.\n5. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.\n6. Contraindications to the use of empagliflozin or linagliptin (per Prescribing Information).\n7. History of recurrent urinary tract infections.","30 Years",{"count":475,"type":21},[54],"In the early postoperative period, hyperglycemia is frequently seen in renal transplant recipients primarily because of high doses of immunosuppressive therapy. Many of these patients have pre-existing type 2 diabetes (T2D). However, 10-20% of renal transplant recipients develop new onset persisting hyperglycemia following renal transplantation, known as posttransplant diabetes mellitus (PTDM). These patients need optimal glycemic control in order to prevent development of cardiovascular and de novo renal disease. Most of these patients receive insulin therapy following transplantation, as they receive steroid therapy and oral hypoglycemic agents are better avoided. However, as steroids are tapered and need for insulin diminishes, several anti-diabetic agents are initiated off-label, such as metformin, DDP-4 inhibitors and sulfonylureas. Sodium-glucose cotransporter-2 (SGLT2) inhibitors exhibit nephroprotective effects in individuals with native kidney disease, with or without type 2 diabetes. However, the data regarding the safety and glycemic efficacy of these glucose-lowering agents in the renal transplant setting are scarce.\n\nDPP-4 inhibitors are glucose-lowering agents used in patients with CKD. For instance, linagliptin is used in all eGFRs without dose modification. The data regarding the safety and efficacy of linagliptin are scarce in patients following renal transplantation.\n\nSince patients following renal transplantation receive immunosuppressants and steroids, which may affect their body composition. Effect of SGLT2 inhibitors or DPP-4 inhibitors on body composition in patients following renal transplantation is not well established.\n\nIn this study, we aimed to examine the safety and effect of empagliflozin (an SGLT2 inhibitor) versus linagliptin (an DDP-4 inhibitor) on the glycemic outcomes, renal outcomes and body composition in renal transplant recipients with diabetes mellitus.",[27,554],"Diabetes Mellitus","2024-12-04",{"date":557,"type":35},"2024-12-05",{"date":559,"type":35},"2023-10-30",{"date":561,"type":21},"2025-12-01",{"name":563,"class":42},"Medanta, The Medicity, India",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":52,"phases":573,"briefSummary":574,"conditions":575,"keywords":584,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":595,"locationsCount":598},"100491430","phase-3-stroke-prophylaxis-with-apixaban-in-chronic-kidney-disease-stage-5-patients-with-atrial-fibrillation-100491430","NCT05679024","Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation","SACK","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n2. 18 years of age or older\n3. Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last year (12 months).\n4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)\n5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation\n6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment\n\nExclusion Criteria:\n\nParticipants may not be included in the study if any of the following criteria are met:\n\n1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)\n2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study\n3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).\n4. Any contraindication for anticoagulation including\n\n   1. endocarditis\n   2. documented intolerance for apixaban\n   3. liver disease with documented coagulation disorder\n   4. pregnancy or breast feeding\n5. Active bleeding or serious bleeding within 3 months, or\n\n   1. documented hemorrhagic blood dyscrasia\n   2. patients currently receiving dual antiplatelet therapy\n6. Planned for surgery\n\n   1. kidney transplantation with a living donor within 3 months\n   2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited\n   3. valvular heart disease surgery\n7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors\n8. Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol)\n\nBeing active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.",{"count":572,"type":21},1400,[157],"Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.\n\nThe secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation.\n\nTrial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months.\n\nTrial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation.\n\nThe exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein.\n\nInterventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation.\n\nOutcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)",[576,577,578,579,580,581,582,27,583],"Chronic Kidney Diseases","Atrial Fibrillation","Stroke","Intracerebral Hemorrhage","Major Bleed","Cardiovascular Complication","Death","Thromboses, Venous",[190,585,586,187,587,588],"Hemodialysis","Peritoneal dialysis","Atrial fibrillation","Oral anticoagulation","2024-10-02",{"date":591,"type":35},"2024-10-04",{"date":593,"type":35},"2023-02-17",{"date":420,"type":21},{"name":596,"class":597},"Region Stockholm","OTHER_GOV",34,{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":17,"minAge":606,"maxAge":18,"enrollmentInfo":607,"targetDuration":4,"studyType":52,"phases":609,"briefSummary":610,"conditions":611,"keywords":613,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":620,"leadSponsor":622,"locationsCount":4},"100561421","stopping-hypertension-and-improving-childrens-lives-after-kidney-transplantation-100561421","NCT06589947","StOPping Hypertension and imprOving Children's Lives After KidnEy TranSplantation","SOPHOCLES","Inclusion Criteria:\n\n* Kidney transplantation \\>12 months ago\n* Arterial hypertension\n\nExclusion Criteria:\n\n* Cardiac malformation\n* Treatment for a rejection episode within three months prior to inclusion","6 Years",{"count":608,"type":21},170,[54],"Cardiovascular (CV) disease is a major morbidity in children after kidney transplantation (KTx), limiting life expectancy and impairing graft function. Arterial hypertension (AH) is the dominant CV risk factor, and highly abundant in this patient group. AH can cause left ventricular hypertrophy (LVH), which is predictive of CV death. LVH can be non-invasively assessed by measuring left ventricular mass index (LVMI). Analyses of observational data showed that blood pressure (BP) levels \\\u003C75th percentile (pct) were associated with a significant reduction of LVMI. Guidelines give BP goals for children with chronic kidney disease (CKD). No guidelines, however, exist on the treatment of AH in pediatric KTx patients. In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation we aim to assess n=500 pediatric patients \\>12 months after KTx at several KTx centers. Patients will be randomly assigned 1:1 to an intensified BP management group (BP target ≤60th pct) and a standard BP management group (BP target \\\u003C90th pct). The primary endpoint is LVMI after 24 months. Secondary endpoints are estimated glomerular filtration rate (eGFR), pulse wave velocity (PWV) and intima media thickness (IMT) after 24 months. BP control will be guaranteed for both groups through BP telemonitoring, which will be transmitted in real time to the treating physician and the trial's centralized BP office. By defining the adequate BP goal, the results of the proposed study will have direct implications for the care of children after KTx. The results will define an important element of post-KTx care and help to lower CV morbidity and subsequently CV mortality of pediatric KTx patients.",[612,27],"Arterial Hypertension",[614,615],"Left ventricular mass","Pediatric kidney transplantation","2024-09-06",{"date":618,"type":35},"2024-09-19",{"date":62,"type":21},{"date":621,"type":21},"2029-03",{"name":623,"class":42},"Hannover Medical School",{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":632,"enrollmentInfo":633,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":635,"conditions":636,"keywords":638,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":43},"100560489","the-outcomes-of-living-donor-robotic-assisted-kidney-transplantation-100560489","NCT06577805","The Outcomes of Living Donor Robotic Assisted Kidney Transplantation","A Retrospective Cohort Study of Prospectively Collect the Outcomes of Recipients After Robot-assisted Kidney Transplantation","RAKT","Inclusion Criteria:\n\n1. living-donor kidney transplant recipients\n2. receiving standard triad immunosuppressive regimen\n\nExclusion Criteria:\n\n1. active infection\n2. multi-organ transplantation\n3. malignancy history in the donor and recipient\n4. human immunodeficiency virus infection","65 Years",{"count":634,"type":21},400,"The technology for robot-assisted kidney transplantation (RAKT) has become increasingly advanced, with numerous studies demonstrating comparable outcomes between RAKT surgery and open surgery. This advancement is particularly noteworthy as it extends its suitability to transplant patients with obesity. It will be important to explore the results of robot-assisted kidney transplantation as compared with open surgery or within cohorts.",[27,637],"Renal Failure Chronic",[639],"robotic surgery","2024-08-29",{"date":642,"type":35},"2024-09-03",{"date":644,"type":35},"2020-07-01",{"date":646,"type":21},"2025-12",{"name":648,"class":42},"West China Hospital"]