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

Bristol-Myers Squibb

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.

Eligibility

Age range: 12–17 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Male and female adolescents 12 to less than 18 years of age * Recipients of a renal allograft from a living or deceased donor transplanted at least 6 calendar months prior to enrollment * Receiving a stable regimen of a calcineurin inhibitor (CNI), with mycophenolate mofetil (MMF) or enteric-coated mycophenolate sodium/mycophenolate mofetil (EC-MPS/MPA), with or without daily corticosteroids for ≥ 30 days prior to randomization * Clinically stable renal function during the 12-week period prior to screening, in the opinion of the investigator and based on protocol-defined…

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

Locations (38)

Local Institution - 0042
Birmingham, Alabama
Local Institution - 0041
Los Angeles, California
Local Institution - 0014
Washington D.C., District of Columbia
Local Institution - 0022
Hollywood, Florida
Local Institution - 0045
Miami, Florida
Local Institution - 0049
Atlanta, Georgia