Comparing immunosuppression strategies in patients with late renal graft failure
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
This study is testing whether continuing low-dose immunosuppression or stopping it after six months is better for people with late kidney transplant failure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06676696 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of continued low-dose immunosuppression versus stopping immunosuppression after six months in patients with late renal graft failure. Participants will be randomly assigned to either continue receiving calcineurin inhibitors for two years or to have their immunosuppressive treatment withdrawn. The primary focus is to assess the degree of HLA sensitization at two years post-treatment. Patients will be monitored through regular clinic visits every three months during the study period.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years who have experienced late renal graft failure and are currently on dialysis.
Not a fit: Patients who have received other solid organ transplants or are waiting for a living donor kidney transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the safest approach to prevent HLA sensitization in patients with late renal graft failure, potentially improving transplant outcomes.
How similar studies have performed: Other studies have explored immunosuppression strategies in transplant patients, but this specific approach to late renal graft failure is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Hospital Universitario Vall D'Hebron — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Francesc Moreso, MD, PhD
- Email: francescjosep.moreso@vallhebron.cat
- Phone: 93 489 30 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.