A multi-centre, open, prospective, randomized, parallel-group, 24-month study to compare the outcome of receiving continued immunosuppression versus stopping immunosuppression at 6 months to safely prevent human leukocyte antigen (HLA) sensitization in patients with late renal graft failure - PREVSENSI

Vall D'hebron Institut De Recerca0 个研究点目标入组 202 人开始时间: 2023年8月3日最近更新: 2024年7月22日

适应症

试验速览

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•Patients eligible for the study must comply with all of the following at randomization: Patient must be able to understand and provide written informed consent; Patients older than 18 years who had received at least one previous renal transplant; Patients with a retained kidney graft failed for any reason which survived at least 3 months; Patients on dialysis, either hemodialysis or peritoneal dialysis; Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria; Patients taking immunosuppressants tacrolimus or cyclosporine; cPRA at the time of randomization = 90%.

•The following patients will be excluded from the study:Patients who have received another solid organ transplantation (liver, lung, heart or pancreas);Patients waiting for a living related / unrelated kidney transplant;Graft survival of the failed graft lower than 3 months; Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria; Pregnant women; •Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study; Patients should use one of the acceptable birth control measures recommended in the document Recommendations related to contraception and pregnancy testing in clinical trials” published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21/09/2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry

发起方

Vall D'hebron Institut De Recerca