[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transplant-recipient-kidney\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transplant-recipient-kidney":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,37,70,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100651731","study-on-precision-dosing-strategies-of-anti-infective-agents-in-the-very-early-stage-of-kidney-transplantation-100651731",false,"NCT07765615","Study on Precision Dosing Strategies of Anti-infective Agents in the Very Early Stage of Kidney Transplantation","Inclusion Criteria:\n\n1. Aged \\>= 18 years old;\n2. Patients receiving kidney transplantation within 0-5 days postoperatively;\n3. Clinically planned administration of anti-infective agents for perioperative prophylaxis, empirical therapy or confirmed infection treatment, with an anticipated treatment duration of no less than 5 days;\n4. Written informed consent obtained from the subject or legal surrogate;\n5. Indwelling urinary catheter retained for at least 48 hours postoperatively to facilitate early urine sample collection;\n6. Patients anticipated to be free of dialysis requirement with urine output or early graft functional recovery at enrollment.\n\nExclusion Criteria:\n\n1. Previous kidney transplantation or combined multi-organ transplantation\n2. Patients requiring continuous renal replacement therapy in the early postoperative period\n3. Severe hepatic dysfunction, defined as Child-Pugh class C, or ALT\u002FAST \\> 5 times the upper limit of normal accompanied by markedly elevated bilirubin\n4. Early postoperative use of ECMO, plasmapheresis or other extracorporeal therapies that substantially alter drug clearance\n5. Pregnancy or lactation\n6. Subjects judged inappropriate for enrollment by investigators, including those with unfeasible sampling, extremely short expected survival, severe missing clinical data, etc.","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","1 Week","OBSERVATIONAL","This study addresses the clinical problem that reliance on serum creatinine, eGFR or empirical dosing fails to accurately adjust anti-infective doses given rapid renal function shifts within the very early 0-5 days post kidney transplantation. We will systematically analyze dynamic trajectories of renal biomarkers (serum creatinine, cystatin C, urine output and other renal function indices), quantify their quantitative associations with the exposure, clearance and pharmacodynamic target attainment of anti-infectives. Combined with clinical profiles, medication data, TDM results and perioperative factors, a population PK\u002FPD model will be built for patients in the very early post-transplant stage. We will further validate the value of dynamic renal markers for individualized anti-infective dosing. This research provides evidence for shifting from static renal function-based empirical dosing to precision dosing guided by real-time renal changes and drug exposure, supporting optimized anti-infective dosage, enhanced efficacy and medication safety in early kidney transplant recipients.",[24],"Transplant Recipient (Kidney)","NOT_YET_RECRUITING","2026-08-11",{"date":28,"type":29},"2026-08-14","ACTUAL",{"date":31,"type":19},"2026-08-25",{"date":33,"type":19},"2027-08-31",{"name":35,"class":36},"Zhongnan Hospital","OTHER",{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":4,"eligibilityCriteria":42,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":43,"enrollmentInfo":44,"targetDuration":4,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100590795","early-phase-1-tolerance-through-mixed-chimerism-sip-tego-100590795","NCT06972069","Tolerance Through Mixed Chimerism (Sip-Tego)","Recipient Inclusion Criteria:\n\n1. Male or female 18-65 years of age.\n2. Subjects with chronic kidney disease stage V (GFR\\\u003C15ml\u002Fmin\u002F1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.\n3. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor\n4. First or second renal transplant.\n5. EBV Seropositive\n6. Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation\n7. Ability to understand and provide informed consent.\n8. Negative COVID-19 test during screening and two days prior to procedure\n\nRecipient Exclusion Criteria:\n\n1. ABO blood group-incompatible renal allograft\n2. Participant with a donor-specific antibody (DSA) within 6 months prior to transplant\n3. Persistent Leukopenia (WBC less than 2,000\u002Fmm3) or thrombocytopenia (\\\u003C100,000\u002Fmm3)\n4. Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.\n5. Untreated Infection\n6. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n7. Forced expiratory volume FEV1 or DLCO \\\u003C 50% of predicted.\n8. Lactation or pregnancy.\n9. Patients with active cancer or those with a high risk of recurrence following the American Transplant Society\n10. Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as non-genetic primary focal segmental glomerulosclerosis dense deposit disease, C3 glomerulonephritis, and, atypical hemolytic uremic syndrome).\n11. Prior dose-limiting radiation therapy for treatment of malignant disease.\n12. Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen. This includes long term cigarette smoking or a family history of malignancy.\n13. Enrollment in other investigational drug studies within 30 days prior to enrollment.\n14. Abnormal (\\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT) , or any patients on chronic anticoagulation therapy.\n15. Allergy or sensitivity to any component of Cyclophosphamide, ATGAM, tacrolimus, Siplizumab, Tegoprubart, or rituximab.\n16. The presence of any medical condition that the investigator deems incompatible with participation in the trial. This includes a history of alcohol abuse or illicit drug use\u002Fdependence.\n17. Any chronic or intermittent administration of immunosuppressant medication (such as for inflammatory bowel disease or asthma)\n18. Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\\\u003C8%). Subjects with severe diabetes-related complications, such as advanced retinopathy, gastroparesis, or severe neuropathy that significantly impair their ability to perform normal, independent daily activities, will also be excluded.\n\nDonor Inclusion Criteria:\n\n1. Male or female 18-70 years of age.\n2. For females of childbearing potential: a serum pregnancy test showing negative results.\n3. Excellent health per conventional pre-donor workup (medical and psychosocial evaluation)\n4. Acceptable laboratory parameters (hematology in normal or near-normal range; Liver function \\\u003C2 times the upper limit of normal, and normal creatinine).\n5. Negative for viral infection with HBV (HbsAg and NAT), HIV (antibody and NAT), HCV (NAT), or HTLV-1.\n6. Cardiac\u002Fpulmonary function within normal limits (CXR, ECG).\n7. Ability to understand and provide informed consent.\n8. Meets standard institutional criteria for bone marrow aspiration and kidney donation.\n9. Negative COVID-19 test during screening and two days prior to procedure","65 Years",{"count":45,"type":19},12,"INTERVENTIONAL",[48],"EARLY_PHASE1","This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.",[51,24,52,53,54],"Kidney Failure","Transplant Tolerance","Immunosuppresion","Immunosuppression After Kidney Transplantation",[56,57,58],"Tolerance","Transplant without immunosuppression","kidney transplant","RECRUITING","2026-07-21",{"date":62,"type":29},"2026-07-22",{"date":64,"type":29},"2025-05-31",{"date":66,"type":19},"2030-12-31",{"name":68,"class":36},"Tatsuo Kawai, MD, PhD",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":46,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":69},"100570021","phase-4-effectiveness-and-cost-effectiveness-of-a-pre-emptive-genotyping-strategy-in-patients-receiving-tacrolimus-100570021","NCT06701825","Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus","A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort","TRANSPGx","Inclusion Criteria:\n\n1. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.\n2. Subject or their legally authorized representative has voluntarily signed the informed consent document.\n3. Participant is on the waiting list for a kidney transplant.\n4. Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.\n5. Subjects must be naïve to any genotyping test of the following genes: CYP3A5.\n\nExclusion Criteria:\n\n1. Known hypersensitivity\u002Fallergy reaction to tacrolimus or any of the excipients.\n2. History of renal, heart, and\u002For liver transplant.\n3. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.\n4. Any condition or situation precluding or interfering the compliance with the protocol.\n5. Any condition at medical discretion for which renal transplantation and\u002For study treatment should not be received.",{"count":79,"type":19},114,[81],"PHASE4","This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.",[84,24,85],"Kidney Disease, Chronic","Immunosuppression",[87,88,89,90,91],"Tacrolimus","Kidney transplant","Cost-effectiveness","Pharmacogenetic","Phase IV Clinical Trial","2025-09-04",{"date":94,"type":29},"2025-09-11",{"date":96,"type":29},"2025-06-02",{"date":98,"type":19},"2026-12-31",{"name":100,"class":36},"Instituto de Investigación Hospital Universitario La Paz",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":69},"100574480","clinical-and-immunological-outcomes-of-living-and-deceased-donor-transplantation-100574480","NCT06759831","Clinical and Immunological Outcomes of Living and Deceased Donor Transplantation","TxBo2022","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Kidney transplant recipient from any donor.\n* Acquisition of Informed Consent to study participation and data processing.\n\nExclusion Criteria:\n\n\\-",{"count":109,"type":19},1293,"This is a retrospective, prospective, single-centre, non-pharmacological observational study.\n\nThe primary objective is to investigate the long-term prognosis of the kidney transplant function of different types of donors.",[24],"2024-12-30",{"date":114,"type":29},"2025-01-06",{"date":116,"type":29},"2024-11-01",{"date":118,"type":19},"2033-10-01",{"name":120,"class":36},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]