drugset / Trial / NCT04877288

A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

NCT04877288

Phase 3 Recruiting 102 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.

Timeline

Start
2021-07-21
Primary completion
2032-12-30
Completion
2034-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Belatacept Protein / enzyme biologic
Subject Cyclosporine Peptide
Subject Tacrolimus Small molecule
Background Mycophenolate Mofetil Small molecule
Background mycophenolic acid Small molecule

Indications

No indication recorded.