Comparing immunosuppression strategies in patients with late renal graft failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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assigned to either continue receiving calcineurin inhibitors for two years or to have their immunosuppressive treatment withdrawn.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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.