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* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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.
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 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
Parallel
Continue low dose calcineurin inhibitor (CNI)
DrugCNI dose (tacrolimus or cyclosporine) will be adjusted to maintain low tacrolimus or cyclosporine whole blood trough levels from month 3 to month 24 or End of Study
Calcineurin inhibitor withdrawal at 6 months
DrugCNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.
Degree of HLA sensitization
The difference between the two treatment arms in the degree of HLA sensitization at 2-years measured as cPRA (%).
Mortality for any reason
The difference between the two treatment arms at 2-years on mortality for any reason
Days of hospitalization for any reason
The difference between the two treatment arms at 2-years on days of hospitalization for any reason
Percentage of patients effectively relisted during follow-up
The difference between the two treatment arms at 2-years on percentage of patients effectively relisted during follow-up
Percentage of patients transplanted
The difference between the two treatment arms at 2-years on percentage of patients transplanted
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