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
Trial Parameters
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Brief Summary
The goal of this clinical trial is 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. The main question this study aims to answer is: Does maintaining long-term immunosuppression in patients with a late renal graft failure (\> 3 months) safely reduce the risk of HLA sensitization? To answer this question, patients will be assigned to a control arm or investigational arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months. * Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years. Patients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.
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 rel