[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"kidney-transplant-failure-and-rejection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:kidney-transplant-failure-and-rejection":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,81,106,139,161,190,223],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100464231","phase-3-a-trial-to-treat-polyomavirus-infections-bkpyv-in-kidney-and-simultaneous-kidney-pancreas-transplant-recipients-100464231",false,"NCT05325008","A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients","An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients","BEAT-BK","Inclusion Criteria:\n\n1. Aged 2 years or above\n2. Have received a kidney or simultaneous pancreas-kidney transplant\n3. Have BKPyV-Viremia (detected by RT-PCR) with a viral count ≥ 5,000 copies per mL, or histological confirmation of BKPyVAN, within 3 weeks prior to randomisation.\n4. Be able to provide informed consent or consent given by a parent or guardian (if age \\\u003C18 years) or other authorised person\n\nExclusion Criteria:\n\n1. Contraindications to receiving IVIG as a treatment\n2. Current active acute rejection (≤ 3 months prior)\n3. Treating clinicians would regard as unsafe to be enrolled\n4. Limited life expectancy (\\\u003C 12 months)\n5. Receiving Belatacept as part of their immunosuppression protocol\n6. Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia\n7. Prior infection and treatment for BKPyV-Viremia\n8. Received IVIG treatment in the past with last IVIG treatment \\\u003C 4 weeks prior to randomisation","ALL","2 Years",{"count":20,"type":21},280,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","BEAT-BK will see the effect of immunosuppression reduction\u002Fmodification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).",[27,28,29],"BK Viremia","Kidney Transplant Infection","Kidney Transplant Failure and Rejection",[31,32,33,34,35,36],"Kidney transplantation","Intravenous immunoglobulin","Virus","Nephropathy","Clinical trial","Nephrology","RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-08","ACTUAL",{"date":43,"type":41},"2023-08-18",{"date":45,"type":21},"2029-06-30",{"name":47,"class":48},"The University of Queensland","OTHER",13,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":78,"locationsCount":80},"100608632","phase-2-tnx-1500-in-kidney-transplant-recipients-100608632","NCT07204080","(TNX-1500) in Kidney Transplant Recipients","Phase II Clinical Trial Evaluating the Safety and Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients","TONIX-1500","Inclusion Criteria:\n\n1. Male or female subjects ≥18 to 75 years of age.\n2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.\n3. Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo or second transplant)\n4. Ability to understand the study requirements and provide written informed consent.\n5. Epstein-Barr virus (EBV) seropositive\n\nExclusion Criteria:\n\n1. Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.\n2. Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.\n3. Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.\n4. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n5. Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n6. Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:\n\n   1. Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.\n   2. Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.\n   3. Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (\\\u003C1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system.\n   4. Total abstinence\n7. Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer.\n8. Subjects with clinically significant lab abnormalities (\\>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition:\n\n   1. Alanine aminotransferase (ALT)\n   2. Aspartate aminotransferase (AST)\n   3. Alkaline phosphatase (ALP)\n   4. Bilirubin\n   5. Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))\n9. Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial.\n10. Subject receives an organ at high risk for delayed graft function, including from a deceased donor after cardiac death (DCD) or a high Kidney Donor Profile Index ≥85%.\n11. Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) \\>20% based upon results within 6 months prior to transplant.\n12. Virtual crossmatch (VXM) positive transplant with an MFI \\>1000 as assessed by routine methodology (Luminex)\n13. Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative\n14. Multi-organ transplant or tissue recipient.\n15. History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix\n16. Subjects with any of the following: hemoglobin \\\u003C8 mg\u002FdL, white blood cell ≤2,000\u002Fmm3, or platelet count ≤75,000\u002Fmm3.","18 Years","75 Years",{"count":61,"type":21},5,[63],"PHASE2","The primary objective is to investigate the safety and efficacy of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.",[66,29,67,68],"Kidney Transplant","Immunosuppression","Immunosuppression After Kidney Transplantation",[66,70],"New Immunosuppression","NOT_YET_RECRUITING","2026-02-24",{"date":74,"type":41},"2026-02-25",{"date":76,"type":21},"2026-07-01",{"date":45,"type":21},{"name":79,"class":48},"Ayman Al Jurdi, MD",2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"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":91,"type":21},24,[93],"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.",[29,96],"Kidney Transplant; Complications","2026-02-06",{"date":99,"type":41},"2026-02-10",{"date":101,"type":21},"2026-03-30",{"date":103,"type":21},"2028-08-25",{"name":105,"class":48},"Northwestern University",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100479632","phase-1-delayed-immunological-tolerance-in-patients-with-well-functioning-pre-existing-hla-matched-kidney-transplants-100479632","NCT05525507","Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants","A Single-armed, Unblinded, Non-randomized Feasibility Study of Hematopoietic Stem Cell Infusion Following a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Anti-thymocyte Globulin (ATG) in Patients With a Pre-existing, Well-functioning HLA-matched Kidney Transplant","Recipient Inclusion Criteria:\n\n1. Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor.\n2. Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion.\n3. No history of rejection with current HLA matched kidney transplant.\n4. Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection.\n5. Stable renal function determined per investigator discretion.\n6. Agreement to participate in the study and ability to give informed consent.\n7. Meets institutional criteria for HSPC infusion.\n8. 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.\n9. No known contraindication to administration of rATG or radiation.\n10. If participant is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) participant 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.\n11. Karnofsky Performance Score (KPS) ≥ 70.\n12. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.\n13. 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.\n14. Adequate social support based on evaluation by the UCLA bone marrow and\u002For renal transplant team.\n\nRecipient Exclusion Criteria:\n\n1. Donor is identical twin.\n2. Major ABO incompatibility with donor\n3. Positive HLA Donor-Specific Antibody (DSA)\n4. History of multi-organ transplantation\n5. History of rejection with current HLA-matched kidney transplant\n6. Known allergy to rabbit proteins\n7. History of post-transplant major complications, including de novo malignancy, active\u002Fchronic infection or rejection, with the exception of low risk, early-stage malignancy with\n\n   ≥90% 5-year survival not receiving chemotherapy or immunotherapy and non-melanomatous skin cancer.\n8. History of active malignancy within the past 5 years with the exception:\n\n   1. Low risk cancer on active surveillance\n   2. Malignancy treated with curative intent with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence\n   3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS)\n9. Worsening renal functioning over preceding 3-month interval determined per investigator discretion.\n10. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n11. Leukopenia (with a white blood cell count \\\u003C 3,000\u002FµL) or thrombocytopenia (with a platelet count \\\u003C 70,000\u002FµL).\n12. EBV, CMV and BK PCR negative at time of HPSC infusion is preferred, but if they have had a history of + CMV\u002FBK PCR, it should be resolved by 3 months.\n13. Active bacterial, fungal, mycobacterial, or viral infection (including active hepatitis B and\u002For C).\n14. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, or HTLV I or II by serum antibody testing.\n15. Renal disease with high risk of recurrence (i.e., focal segmental glomerulosclerosis).\n16. Advanced hepatic fibrosis or cirrhosis secondary to hepatitis B and\u002For C diagnosis.\n17. 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.\n18. Active extra-renal autoimmune disease requiring immunosuppression.\n19. Neuropsychiatric illness that precludes the ability to give informed consent and\u002For places the participant as high risk for non-compliance with the safety monitoring requirements of the study.\n20. May not have received other immunomodulatory agents, including but not limited to tumor necrosis factor inhibitors 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.\n21. 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.\n22. Current or active abuse of alcohol and\u002For drugs within last 6 months.\n23. Body Mass Index (BMI) ≥ 40.\n\nDonor Inclusion Criteria:\n\n1. HLA-matched sibling on high-resolution HLA typing who\n\n   a. is ≥18 years of age.\n2. Must meet institutional criteria for HSPC transplant donation.\n3. Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥11, white blood cell count ≥ 3,000\u002FµL, and platelets ≥ 100,000\u002FµL.\n4. Serum creatinine as expected post-kidney donation and coagulation parameter studies; or, if abnormal, the changes are not considered clinically significant.\n\nDonor exclusion criteria:\n\n1. Recipient is identical twin.\n2. Major ABO incompatibility with recipient.\n3. Medically unfit to tolerate peripheral blood apheresis (e.g. small body size, poor vascular access, not a suitable candidate for placement of a central catheter).\n4. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n5. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, HTLV I or II by serum antibody testing\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.\n9. History of active malignancy within the past 5 years with the exception:\n\n   1. Low risk cancer on active surveillance\n   2. Malignancy treated with curative intent with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence\n   3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, and DCIS)\n10. No use of oral anticoagulants 2 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 7 days prior to apheresis, however subjects who are taking aspirin for its anti- platelet\u002Fanti-thrombotic effect, are excluded.",true,{"count":115,"type":21},10,[93],"The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).",[119,120,29,121],"End Stage Kidney Disease","Immunological Tolerance","Chronic Kidney Diseases",[123,124,125,126,127,128],"immunological tolerance","kidney transplant","tolerance","end stage kidney disease","end stage renal disease","chronic kidney disease","2025-11-21",{"date":131,"type":41},"2025-11-26",{"date":133,"type":41},"2022-12-21",{"date":135,"type":21},"2026-12",{"name":137,"class":48},"University of California, Los Angeles",1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100604163","to-explore-the-application-value-of-magnetic-resonance-imaging-in-noninvasive-quantitative-evaluation-of-graft-function-and-systemic-metabolism-after-renal-transplantation-100604163","NCT07145944","To Explore the Application Value of Magnetic Resonance Imaging in Noninvasive Quantitative Evaluation of Graft Function and Systemic Metabolism After Renal Transplantation","Inclusion Criteria:\n\n* (1) Patients with MR examination after kidney transplantation;\n\n  (2) Age\u002Fgender: unlimited;\n\n  (3) Patients who voluntarily participate in clinical trials and sign written subject informed consent\n\nExclusion Criteria:\n\n\\- (1) Patients with pacemakers, unknown materials, metal implants, neurostimulators, claustrophobia, etc.\n\n(2) Patients who cannot tolerate adequate breath-holding for adequate MR examination;",{"count":146,"type":21},500,"OBSERVATIONAL","At present, renal biopsy is the gold standard for evaluating the pathology of renal transplants, but it is invasive and has the risk of serious complications; and the sampled tissue is only a small part of the kidney, which is prone to sampling bias and lacks reliable and comprehensive detection results. Therefore, it is an urgent problem to develop a non-invasive dynamic detection method for renal insufficiency and transplanted kidney.\n\nWith the continuous development and updating of technology, imaging provides a new way for non-invasive evaluation of renal allograft pathology including rejection reaction, acute renal allograft injury, viral infection, etc. MRI technology has developed the diagnosis of renal allograft rejection, fibrosis and other renal allograft dysfunction from macroscopic simple biomorphological changes to microscopic complex pathophysiological changes due to its high resolution of soft tissue and its ability to perform multi-parameter analysis.\n\nIn recent years, under the background of precision medicine, artificial intelligence technologies such as radiomics and machine learning are rapidly becoming very promising auxiliary tools in the evaluation of transplanted kidney images. They can extract and learn features in images with high throughput, make greater use of information that cannot be recognized by human eyes in medical images, and realize disease diagnosis, prognosis evaluation, and curative effect prediction by establishing models. However, most of the current research is in the preliminary stage. There are few evaluation studies on kidney transplantation. It is believed that with the continuous improvement of algorithms and optimization of models, radiomics and machine learning will make great progress, which will promote the development of individualized and precise medicine for patients with renal insufficiency to a certain extent.",[29,150,151],"Transplantation, Kidney","Kidney Transplant Dysfunction","2025-08-21",{"date":154,"type":41},"2025-08-28",{"date":156,"type":21},"2025-09-01",{"date":158,"type":21},"2031-12-12",{"name":160,"class":48},"Tongji Hospital",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":113,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":138},"100359061","efficiency-of-everolimus-for-the-treatment-of-kidney-transplanted-patients-presenting-a-missing-self-induced-nk-mediated-rejection-100359061","NCT03955172","Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection","Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced Natural Killer Cells Mediated (NK-mediated) Rejection","STARR","Inclusion Criteria:\n\n* Patient aged \\> 18 years\n* Kidney transplanted patient\n* Having microvascular inflammation lesion on his graft biopsy associated to mild chronic lesions\n* In absence of donor specific antibodies\n* In presence of a missing self\n\nExclusion Criteria:\n\n* Proteinuria\u002Furinary creatinin \\> 100 mg\u002Fmmol\n* Antecedent of poor tolerance or hypersensibility to everolimus or sirolimus\n* Severe chronic lesions\n* Presence of donor specific antibodies",{"count":170,"type":21},20,[172],"NA","Background:\n\nLong-term success of organ transplantation is limited by the inexorable loss of graft function due to rejection. Prevalent dogma defends that allograft rejection is exclusively mediated by the adaptive immune system: T cells are responsible for cellular rejections and B cells producing Donor Specific Antibodies (DSA) are responsible for humoral rejection. Recently, we demonstrated that innate NK cells could be implicated in the generation of chronic vascular rejections lesions by sensing the absence of expression of self Major Histocompatibility Complex (MHC) class I molecules (\"missing self\") on graft endothelial cells with their Killer cell immunoglobulin-like (KIR) receptors. Using human in vitro and murine in vivo models, we also showed that Mammalian Target Of Rapamycin (mTOR) inhibitors could efficiently prevent this new kind of rejection.\n\nObjective:\n\nThe aim of our project is therefore to test in a cohort of kidney transplanted patients the efficiency of mTOR inhibitors to treat this new kind of rejection\n\nMethods:\n\nA cohort of 20 kidney transplant patients with a missing self on their graft responsible for a NK-mediated rejection will be established prospectively. An mTOR inhibitor will be introduced in these patients for 6 months in association with a calcineurin inhibitor and corticosteroids. Graft function, histological lesions and NK activability will be monitored following this modification of treatment.",[29],[176,177,178,179,180],"Missing self","NK cells","Rejection","mTOR inhibitors","Kidney transplanted patients","2024-06-05",{"date":183,"type":41},"2024-06-06",{"date":185,"type":41},"2020-12-03",{"date":187,"type":21},"2027-12-03",{"name":189,"class":48},"Hospices Civils de Lyon",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":198,"targetDuration":200,"studyType":147,"phases":4,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":4},"100461002","assessment-of-qsant-for-underlying-allograft-rejection-100461002","NCT05282966","Assessment of QSant™ for Underlying Allograft Rejection","Assessment of QSant™ for Underlying Allograft Rejection (AQUA Registry)","AQUA","Inclusion Criteria:\n\n1. Kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant.\n2. Able to understand risks and requirements of participation and provide informed consent\n3. Willing and able to comply with the study requirements\n\nExclusion Criteria:\n\n1. Inability to provide a voided urine sample per collection protocol\n2. Urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.",{"count":199,"type":21},4000,"24 Months","The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test. QSant is a test based on 6 urinary biomarkers including cell-free DNA, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.",[29],[124,204,205,206,207,208,209,210,211,212],"kidney biopsy","allograft rejection","subclinical allograft rejection","kidney","kidney health","kidney function","urine sample","urine test","kidney disease","2022-09-26",{"date":215,"type":41},"2022-09-28",{"date":217,"type":21},"2023-03",{"date":219,"type":21},"2026-10",{"name":221,"class":222},"NephroSant","INDUSTRY",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":147,"phases":4,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":80},"100402910","tacrolimus-pharmacokinetic-subpopulations-100402910","NCT04526431","Tacrolimus Pharmacokinetic Subpopulations","Tacrolimus Pharmacokinetic Subpopulations: Prospective Mechanistic Investigations of the Tacrolimus C\u002FD Ratio","TIPS","Inclusion Criteria:\n\n* Kidney transplant patients at the CHUGA, CHU Saint-Etienne or CHU Clermont-Ferrand, whose new transplant is no more than 7 days old (inclusive)\n* Patients initially treated with tacrolimus as an immunosuppressant, combined with mycophenolate (MMF), mycophenolic acid (MPA) or everolimus (EVR), with or without corticotherapy.\n* No plans to remove tacrolimus from the patient's immunosuppressive treatment (e.g. no plans to switch to belatacept a priori), during the first 4 years post-transplantation.\n* Affiliation to or beneficiary of a social security scheme\n* Able to read and understand the terms of the protocol\n* Informed consent obtained, including specific consent for genetic analysis of target genes.\n* For women of childbearing potential, presence of effective contraception (already acquired for patients treated with mycophenolic acid as an immunosuppressant).\n\nExclusion Criteria:\n\n* Contraindication to the use of tacrolimus\n* Patient already treated with tacrolimus at the time of transplantation\n* Pregnant, parturient or breastfeeding women\n* Patient deprived of liberty by judicial or administrative decision\n* Patient under guardianship or curatorship, or receiving forced psychiatric care\n* Person admitted to a health or social institution\n* Subject cannot be contacted in case of emergency\n* Subject in period of exclusion from another study",{"count":232,"type":21},180,"This prospective study will investigate the concentrations of tacrolimus metabolites (M-I and M-III) over the four first years post-transplantation.\n\nA differential metabolism might result in different metabolites' concentration and explain a kidney survival difference between \"high rate metabolism\" (defined as a concentration\u002Fdose ratio, C\u002FD ratio, lower than 1.04 µg\u002Fl\u002Fmg) and other patients.\n\nThe primary endpoint is therefore to compare tacrolimus metabolites' concentrations with respect to the group, either \\\u003C or \\>= 1.04 µg\u002Fl\u002Fmg, in order to detect differences in tacrolimus metabolization between these groups.",[29,235],"Immunosuppression-related Infectious Disease",[31,237,238,239,240],"Pharmacokinetic","Tacrolimus","Concentration-dose ratio","Pharmacogenetic","2021-02-09",{"date":243,"type":41},"2021-02-10",{"date":245,"type":41},"2020-07-28",{"date":247,"type":21},"2027-08-01",{"name":249,"class":48},"University Hospital, Grenoble"]