NCT02137239

Regimen Optimization Study

Evaluation of Acute Rejection Rates in de Novo Renal Transplant Recipients Following Thymoglobulin Induction, CNI-free, Nulojix (Belatacept)-Based Immunosuppression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Calcineurin inhibitor (CNI)

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Thymoglobulin
DRUG	Belatacept
DRUG	mycophenolate mofetil(MMF)
DRUG	Corticosteroids
DRUG	Everolimus(EVL)
DRUG	Tacrolimus(TAC)

Timeline

• Start date: 2015-12-31
• Primary completion: 2019-05-02
• Completion: 2019-05-02
• First posted: 2014-05-13
• Last updated: 2021-06-22
• Results posted: 2021-06-22

Locations

20 sites across 2 countries: United States, Argentina