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

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · Nov 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether continuing low-dose immunosuppressant medication for two years can help prevent HLA sensitization in patients who have experienced late renal graft failure, which means their kidney transplant has not worked well for at least three months. HLA sensitization can make it harder to find a suitable kidney donor in the future. The trial will compare two groups: one group will stop their immunosuppressant treatment after six months, while the other will continue with reduced doses for the full two years.

To be eligible for this trial, participants must be at least 18 years old, have had at least one kidney transplant, and be on dialysis (a treatment for kidney failure) for no more than six months. They should also be able to give informed consent and meet other specific health criteria. Throughout the study, participants will have checkups every three months to monitor their health and the outcomes of the treatment. This trial is currently recruiting patients, and it aims to provide valuable insights into the best ways to manage kidney transplant health after graft failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • 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%
• Exclusion Criteria:
• • 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
• • 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.