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

A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Allograft Recipients

Interventions

Type	Name	Description
BIOLOGICAL	Belatacept	Specified dose on specified days
DRUG	Tacrolimus	Specified dose on specified days
DRUG	Cyclosporine A	Specified dose on specified days
DRUG	Mycophenolate Mofetil	Specified dose on specified days
DRUG	Enteric Coated Mycophenolate Sodium	Specified dose on specified days
DRUG	Corticosteroids	Specified dose on Specified days

Timeline

• Start date: 2021-07-21
• Primary completion: 2032-12-30
• Completion: 2034-06-30
• First posted: 2021-05-07
• Last updated: 2026-02-03

Locations

38 sites across 10 countries: United States, Argentina, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, United Kingdom

Regulatory

• FDA-regulated drug study