NCT00256750

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 738 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.

Conditions

• Kidney Transplantation
• Chronic Kidney Failure

Interventions

Type	Name	Description
DRUG	Cyclosporine (CsA)	tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months (ST), 100-250 ng/mL, daily, 24 months (LT)
DRUG	Belatacept LI (less intensive)	solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
DRUG	Belatacept MI (more intensive)	solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-06-01
• Completion: 2015-04-01
• First posted: 2005-11-22
• Last updated: 2016-08-19
• Results posted: 2016-08-19

Locations

105 sites across 21 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye)