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 statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

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* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Continue low dose calcineurin inhibitor (CNI)
  • Calcineurin inhibitor withdrawal at 6 months

Treatment groups

202 Participants
are divided into 2 treatment groups