Evaluation of Conversion from Calcineurin Inhibitor- to Belatacept-based Immunosuppression inAdolescent Renal Transplant Recipients and their Compliance with ImmunosuppressiveMedications
Phase 1
Recruiting
- Conditions
- Adolescent Renal AllograftsMedDRA version: 21.0Level: PTClassification code: 10038533Term: Renal transplant Class: 100000004865Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-501677-39-00
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 109
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method