At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 738 enrolled

Drug / intervention

Cyclosporine (CsA) +2 moredrug

Likely dose

Belatacept LI (less intensive) 10mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00256750

NCT00256750Phase 3Completed

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

Bristol-Myers Squibb·interventional·Posted Nov 22, 2005·Updated Aug 19, 2016

In Brief

A Phase 3 clinical trial evaluating Cyclosporine (CsA), Belatacept LI (less intensive), and 1 other intervention for Kidney Transplantation and Chronic Kidney Failure. Completed, enrolled 738 participants across 105 sites in 21 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsKidney Transplantation, Chronic Kidney Failure

CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United States

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2005

First PostedNov 2005

Primary CompletionJun 2008

Study CompletionApr 2015

TodayJul 2026

First PostedNov 22, 2005

Enrollment StartMar 1, 2005

Primary CompletionJun 1, 2008

Study CompletionApr 1, 2015

TodayJul 2, 2026

Enrollment to primary: 3.3 yearsPosted 20.6 years ago

Interventions

Cyclosporine (CsA)drug

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)

Belatacept LI (less intensive)drug

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)

Belatacept MI (more intensive)drug

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)