drugset
drugset / Trial / NCT06055608

Advancing Transplantation Outcomes in Children

NCT06055608 ↗

Phase 2 Recruiting 200 enrolled National Institute of Allergy and Infectious Diseases (NIAID)
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Timeline

Start
2024-05-22
Primary completion
2028-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Belatacept Protein / enzyme biologic 5 mg/kg Intravenous
Comparator Mycophenolate Mofetil Small molecule 450 mg/m2 —
Subject Sirolimus Small molecule 1 mg/m2 —
Subject Sirolimus Small molecule 2 mg —
Subject Tacrolimus Small molecule 0.1 mg/kg —
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 1.5 mg/kg —

Indications

No indication recorded.