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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-03

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2032-12-30
Completion
2034-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877288 on ClinicalTrials.gov