BridgeMD
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
EU CTIS ID: 2023-506879-98-00
What this study is testing
To compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted. This period may be extended up to 12 months if the immunosuppressive regimen has remained stable and has not been reduced by more than 50%.; 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%.
You likely can't join if
- 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 in dialysis more than 6 months at the time of randomization, unless they have maintained a stable immunosuppressive regimen (calcineurin inhibitors and steroids, without reductions greater than 50%) since dialysis was restarted; in that case, patients will be excluded if they have been on dialysis for more than 12 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.