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drugset / Trial / NCT02137239

Regimen Optimization Study

NCT02137239 ↗

Phase 2 Completed 58 enrolled Bristol-Myers Squibb
RandomizedParallel-groupOpen-labelTreatment

Summary

Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit damage to or the possibility of rejecting the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.

Timeline

Start
2015-12-31
Primary completion
2019-05-02
Completion
2019-05-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Belatacept Protein / enzyme biologic 5 mg/kg Intravenous
Subject Everolimus Small molecule 3 mg Oral
Subject Mycophenolate Mofetil Small molecule 0.5 g Oral
Subject Mycophenolate Mofetil Small molecule 2 g Oral
Subject Mycophenolate Mofetil Small molecule 3 g Oral
Subject Tacrolimus Small molecule 0.1 mg/kg Oral
Background Methylprednisolone Other / unclassified — Intravenous
Background Prednisone Other / unclassified — Oral
Background Thymoglobulin Protein / enzyme biologic 3 mg/kg Intravenous
Background Thymoglobulin Protein / enzyme biologic 5.5 mg/kg Intravenous

Indications

No indication recorded.