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
Phase 3
Recruiting
- Conditions
- Kidney transplantRenal Allograft10038430
- Registration Number
- NL-OMON52226
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 3
Inclusion Criteria
- Male and females between 12 to less than 18 years of age
- Documented EBV seropositivity prior to transplant and randomization
- Receiving a stable regimen of a CNI with a mycophenolate with or
without concomitant corticosteroids for > 1 calendar month prior to
randomization
- Stable renal function 12 weeks prior to screening based upon
investigator assessment and protocol-defined criteria for eGFR and proteinuria
Exclusion Criteria
- No treatment for biopsy-proven acute rejection (BPAR) of any degree
of severity within 6 calendar months prior to enrollment.
- No history of biopsy confirmed antibody mediated rejection or Banff
Grade IIA or higher acute cellular rejection with the current transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>Proportion of participants who survive with a functional graft with an eGFR ><br /><br>30 mL/min/1.73 m2 (updated Schwartz formula) at 24 months post-randomization.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints<br /><br>• Participant and graft survival: Proportion of participants who:<br /><br>* survive with a functioning graft at 6 and 12 months post-randomization.<br /><br>* survive at 6, 12 and 24 months post-randomization.<br /><br>* experience death-censored graft loss by 6, 12 and 24 months post<br /><br>randomization.</p><br>