RecruitingPhase 4NCT06676696

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

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


Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrollment

202 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

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arm: * Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches after a transplanted kidney fails: continuing immunosuppressive (anti-rejection) medications versus stopping them at 6 months. The goal is to see which approach better prevents the immune system from developing antibodies that would make future transplants harder. **You may be eligible if...** - You are over 18 and have had at least one kidney transplant in the past - Your transplanted kidney has failed and you are back on dialysis - Your failed kidney has been in place for at least 3 months - You still have the failed kidney in your body (it has not been removed) **You may NOT be eligible if...** - Your failed kidney has already been removed (prior to study entry) - You have active serious infections or cancer - You are unable to tolerate immunosuppressive medications - You do not meet other safety criteria determined by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGContinue low dose calcineurin inhibitor (CNI)

CNI 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

DRUGCalcineurin inhibitor withdrawal at 6 months

CNI dose (tacrolimus or cyclosporine) will be reduced to one-half on month 3 visit and completely withdrawn on month 6 visit.


Locations(1)

Hospital Universitario Vall D'Hebron

Barcelona, Spain

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NCT06676696


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