NCT00114777

Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 595 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Cyclosporin A	tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months
DRUG	Belatacept Less Intensive Regimen (LI)	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 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months
DRUG	Belatacept More Intensive Regimen (MI)	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, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-05-01
• Completion: 2014-09-01
• First posted: 2005-06-20
• Last updated: 2017-07-07
• Results posted: 2017-07-07

Locations

79 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hungary, Italy, Norway, Poland, South Africa, Spain, Sweden, United Kingdom