[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-transplant-rejection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-transplant-rejection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,75,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100468872","phase-3-induction-in-sensitized-kidney-transplant-recipients-without-pre-existing-donor-specific-antibodies-100468872",false,"NCT05385432","Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies","Induction in Sensitized Kidney Transplant Recipients Without Preexisting Donor-specific antiboDies: a Randomized Multicentre Trial Between a Lymphocyte Depleting and Basiliximab.","INSTEAD","Inclusion Criteria:\n\n* Patients aged between 18-79\n* Registered on the transplant waiting list\n* At least one anti-HLA antibody identified by the Luminex Single Antigen test with MFI ≥ 2000 (MFI threshold in agreement with French kidney allocation system.)\n* Graft incompatibility rate (TGI) \\\u003C 85%\n* Ability for participant to comply with the requirements of the study\n* Written informed consent obtained from the participant\n* Participants covered by or entitled to social security.\n\nExclusion Criteria:\n\n* DSA (negative virtual crossmatch with MFI threshold at 1000)\n* Combined transplantation\n* Usual contraindications to a kidney transplantation such as morbid obesity (BMI \\> 40 kg\u002Fm2), active drug abuse, uncontrolled psychiatric disease, or decompensated heart failure\n* Beneficiaries of kidney transplants from donations after uncontrolled circulatory death (Maastricht II)\n* Incompatible ABO transplantation\n* Leukopenia lower than 3000\u002Fmm3\n* Thrombocytopenia (platelets \\\u003C 50G\u002FL)\n* Donor EBV Positive \u002F Recipient EBV Negative\n* Active HIV infection (positive viral charge)\n* History of solid cancer (\\\u003C 5 years), except to skin carcinoma (squamous-cell and basal-cell carcinoma).History of some solid cancer (prostate, breast) can be reduced (\\\u003C2 years), depending on the prognosis for cancer recurrence as assessed by the oncologist.\n* History of lymphoma\n* Patients with severe uncontrolled systemic infection or severe allergy requiring acute or chronic treatment; Aspartate aminotransferase (ASAT), Alanine Amino Transferase (ALAT) or bilirubin greater than 3 times normal\n* Known hypersensitivity or contra-indication to rabbit proteins, basiliximab including the product excipients\n* Contra-indication to tacrolimus,mycophenolic acid ans steroids\n* Pregnant or breastfeeding woman, or woman of childbearing potential not using a highly effective method of contraception, or having a desire to conceive, during the whole trial duration. A β-HCG test will be performed for inclusion.\n* Patient under judicial protection, deprivation of liberty\n* Participation in other interventional research with an investigational drug or medical device.","ALL","18 Years","79 Years",{"count":21,"type":22},244,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Induction therapy decreases the rate of acute allograft rejection in kidney transplant recipients (KTRs) and is strongly recommended. Polyclonal lymphocyte-depleting antibodies and interleukin-2 receptor (IL2R) antagonists are therefore widely used around the world, with a leading position for rabbit anti-thymocyte globulin (rATG, Thymoglobulin®) and basiliximab (Simulect®), respectively. The actual immunological risk of the sensitized KTRs without donor specific antibodies (DSAs) is still debated. The benefit-risk equation of lymphocyte depleting antibodies (versus IL2R antagonists) is not known in sensitized KTRs without DSAs. This clinical trial will compare the efficacy and safety of basiliximab and rATG in sensitized KTR without pre-existing DSAs detected by Luminex.",[28,29],"Renal Transplant Rejection","Induction Therapy",[31,32,33,34,35],"Kidney transplantation","Basiliximab","ATG","induction","rejection","RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2023-11-07",{"date":44,"type":22},"2030-12-30",{"name":46,"class":47},"University Hospital, Tours","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100340034","phase-1-study-of-combined-kidney-and-blood-stem-cell-transplant-from-a-brother-or-sister-donor-100340034","NCT03707262","Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor","Donor Chimerism and Graft Survival Following Combined HLA-Identical Sibling Living Donor Kidney and Hematopoietic Stem Cell Transplantation Utilizing a Conditioning Regimen of Total Lymphoid Irradiation and Rabbit Anti-Thymocyte Globulin","Recipient Inclusion Criteria:\n\n1. Males and females ages 18 years and older receiving living donor kidney transplant from an HLA-identical sibling at UCLA Medical Center.\n2. Agrees to participate in the study and is able to give informed consent.\n3. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion.\n4. Meets institutional criteria for kidney and HSPC transplant.\n5. No known contraindication to administration of rATG or radiation.\n6. If patient is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) patient must be confirmed not pregnant by a serum or urine pregnancy test) and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for at least 12 months post-transplant. Karnofsky Performance Score ≥ 70.\n7. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.\n8. Adequate pulmonary function defined as FVC and DLCO of greater than or equal to 50% of predicted.\n9. Adequate liver function defined as total bilirubin ≤ 1.5 times the upper limit of normal and AST\u002FALT ≤ 2.0 times the upper limit of normal.\n10. Adequate social support based on evaluation by the UCLA renal transplant team licensed clinical social worker.\n\nRecipient Exclusion Criteria:\n\n1. Donor is identical twin.\n2. ABO incompatibility with donor.\n3. Previous solid organ transplant\n4. Multi-organ transplantation\n5. Previous treatment with rATG or a known allergy to rabbit proteins\n6. History of active malignancy within the past 5 years with the exception of non-melanomatous skin cancer.\n\n   a. History of another primary malignancy except for: i. Malignancy treated with curative intent and with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence ii. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease iii. Very low risk and low risk cancer adequately treated or on active surveillance b. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS)\n7. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n8. Leukopenia (with a white blood cell count \\\u003C 3,000\u002F µL) or thrombocytopenia (with a platelet count \\\u003C 100,000\u002F µL).\n9. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C).\n10. Positive HLA DSA\n11. Seropositivity for HIV 1, HIV 2, HTLVI, HTLV II\n12. Active West Nile Virus infection\n13. Renal disease with high risk of recurrence (i.e., focal segmental glomerulosclerosis).\n14. Advanced hepatic fibrosis or cirrhosis secondary to hepatitis B and\u002For C diagnosis.\n15. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; active extra-renal autoimmune disease requiring immunosuppression.\n16. Active extra-renal autoimmune disease requiring immunosuppression.\n17. Neuropsychiatric illness that precludes the ability to give informed consent and\u002For places the patient as high risk for non-compliance with the safety monitoring requirements of the study.\n18. May not have received other immunosuppressive medications, including but not limited to alemtuzumab, belatacept, sirlolimus, everolimus, azathioprine, basiliximab, and eculizumab within six months of the study treatment. Use of corticosteroids prescribed for a time-limited indication (\\\u003C\u002F= 4 weeks) and stopped at least 4 weeks before the kidney transplant is acceptable.\n19. May not have received immunotherapy drugs such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, and interleukin-2 within six months of the study treatment.\n20. Current or active abuse of alcohol and\u002For drugs within last 6 months.\n21. BMI 40 or greater.\n\nDonor Inclusion Criteria:\n\n1. HLA-identical sibling on high-resolution HLA typing who is ≥18 years of age.\n2. Meets institutional criteria for living kidney and allogeneic HSPC transplant donation.\n3. Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥ 11 g\u002FdL, white blood cell count ≥ 3,000\u002FµL, and platelets ≥120,000\u002FµL.\n4. Normal serum chemistry and coagulation studies; or, if abnormal, the differences are not considered clinically significant.\n\nDonor Exclusion Criteria:\n\n1. Recipient is identical twin.\n2. ABO incompatibility with recipient.\n3. Medically unfit to tolerate peripheral blood apheresis (small body size, poor vascular access, not a suitable candidate for placement of a central catheter, etc.).\n4. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n5. Seropositivity for HIV 1, HIV 2, HTLV I, HTLV II\n6. Active West Nile Virus infection\n7. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C)\n8. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study\n\n   1. History of active malignancy within the past 5 years with the exception:Adequately managed malignancy within the past two years with low risk of recurrence may be acceptable as per clinician discretion\n   2. Adequately managed non-melanoma skin cancer\n   3. Adequately managed carcinoma in situ e.g., cervical cancer in situ, and DCIS\n9. No current or recent use of oral anti-coagulants. (For the purpose of this study, recent is defined as less than 60 days prior to apheresis.). Note: Use of aspirin and non-steroidal anti-inflammatory drugs, for pain and inflammation management purposes, are permitted to enroll in the study, but these drugs must be stopped 14 days prior to apheresis, however subjects who are taking aspirin for its anti-platelet\u002Fanti-thrombotic effect, are excluded.",{"count":57,"type":22},15,[59,60],"PHASE1","PHASE2","The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor.\n\nThe investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as \"mixed chimerism.\" Mixed chimerism may help create a state of \"tolerance\" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney.\n\nThis study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.",[28,63,64],"Tolerance","Kidney Transplant",[63,64],"2026-05-06",{"date":68,"type":40},"2026-05-08",{"date":70,"type":40},"2019-11-06",{"date":72,"type":22},"2027-05",{"name":74,"class":47},"Jeffrey Veale, MD",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":48},"100549751","deep-phenotyping-of-the-renal-allograft-to-prognosticate-clinical-outcomes-100549751","NCT06438107","Deep Phenotyping of the Renal Allograft to Prognosticate Clinical Outcomes","Inclusion Criteria:\n\n1. All adult living or deceased donor renal transplant recipients (age ≥ 18 years), irrespective of gender, race, or ethnic background.\n2. Able to understand and provide inform consent.\n\nExclusion Criteria:\n\n1. Medical contraindications to undergo renal biopsy (use of long-term anticoagulation, low platelet count of \\\u003C100,000\u002FuL)\n2. Cause of ESRD likely to recur in transplant: Hemolytic uremic syndrome (HUS)\n3. Not maintained on standard of care immunosuppression therapy (Thymoglobulin induction followed by tacrolimus and mycophenolate maintenance)",{"count":82,"type":22},24,"OBSERVATIONAL","The goal of this observational study is to determine phenotypic, transcriptional, and epigenetic underpinnings of renal allograft rejection in renal transplant rejection. The main questions it aims to answer are:\n\n* To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in acute ejection.\n* To determine the phenotype, frequency, location, and the inter-cellular interactions between the cells that constitute intra-graft inflammatory infiltrate in recurrent\u002Frecalcitrant rejection vs. rejection that resolves with therapy.\n* To generate a scRNA sequencing (scRNAseq) map of the intra-graft immune cells and the renal parenchymal cells and compare the transcriptional and epigenetic changes within these cells in recurrent\u002Frecalcitrant rejection vs. rejection that resolves with therapy.\n* To determine phenotypic changes associated with chronic rejection.\n\nParticipants will be asked to provide the following research specimens:\n\n* Renal biopsy specimens at the following timepoints: day of transplantation (pre-implantation and post-perfusion); routine protocol biopsies at 3 months and 12 months; and clinically indicated for-cause biopsies at any timepoint from time-0 to 1-yr post-transplantation. The 1st research core will be used for routine histopathological examination and left over tissue from this core will be used for deep phenotyping using multiparameter immunophenotyping, and digital spatial profiling. The second research core will be used for extraction of cells and nuclei for scRNAseq and snATACseq.\n* Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses). For each collection timepoint, up to 75 mL (about 5 tablespoons) will be collected.\n* Prospective clinical data and outcomes will be collected from participant medical records.\n* Follow-Up Period: For-cause biopsies from 1-yr to 5-yr post-transplantation (by the transplant nephrologist): no additional cores will be obtained for research from these biopsies. The left-over tissue from the clinically indicated biopsy cores will be analyzed by deep phenotyping and digital spatial profiling. Blood samples will be processed to obtain plasma (for cytokine, chemokine and DSA measurements) and PBMC (for deep phenotyping and molecular analyses).",[28],[87,88],"Organ rejection","Acute rejection","NOT_YET_RECRUITING","2025-12-18",{"date":92,"type":40},"2025-12-26",{"date":94,"type":22},"2026-04",{"date":96,"type":22},"2030-07",{"name":98,"class":47},"University of Pittsburgh",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":48},"100300510","multi-parametric-mri-for-renal-transplantation-100300510","NCT03192007","Multi-Parametric MRI for Renal Transplantation","Inclusion Criteria:\n\n* Renal Transplant Recipients\n* Capable to consent\n* English speaking\n* For studies with patients with fast worsening renal function: An abrupt (within 48 h) reduction in kidney function currently defined as a percentage increase in serum creatinine of ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 mL\u002Fkg\u002Fh for more than 6 h).\n* For patients with recovered renal allograft function after therapy: renal allograft function as measured by glomerular filtration rate (eGRF) has been recovered and stabilized above a clinical acceptable level, such as 15 ml\u002Fmin\u002F1.73 mm2.\n\nExclusion Criteria:\n\n* On dialysis due to renal allograft failure\n* Acute and chronic pulmonary disease\n* Pregnancy as reported in CMRR Safety Screen\n* Ferromagnetic implants\n* Any foreign metal objects in the body\n* History of shrapnel or shot gun injury\n* Cardiac pacemakers\n* Defibrillator\n* Neuronal stimulator\n* Magnetic aneurysm clip\n* Large tattoos on the abdomen or the brain and neck, as determined by CMRR Safety Officer\n* Hip replacement\n* Too large to fit in the magnet (BMI \\>= 40, approx.)\n* Severe claustrophobia","75 Years",{"count":107,"type":22},140,"The goals of this study are:\n\n* To optimize and evaluate multiple kidney MRI methods; and\n* To investigate the potential of MRI in the assessment of transplant kidney functions; To achieve these goals, we will perform pilot MRI studies with kidney transplant patients. We will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.\n\nYou may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the center for magnetic resonance research (CMRR): the 3 Tesla (3T) scanner and the 7 Tesla (7T) scanner. You may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.",[28],"2025-09-25",{"date":112,"type":40},"2025-09-29",{"date":114,"type":22},"2027-07-01",{"date":116,"type":22},"2028-12-31",{"name":118,"class":47},"University of Minnesota"]