CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 595 enrolled
Drug / intervention
Cyclosporin A +2 moredrug
Likely dose
Belatacept 10 mg/kg on Days 1 and 5, then per intensive or less intensive regimen (5 mg/kg every 4 weeks maintenance); Cyclosporin A target 150-300 ng/mL 1st month, then 100-250 ng/mLAI-extracted
Key inclusion· 1
  • ✓First-time recipient of a kidney transplant from a deceased donor
Key exclusion· 9
  • ✕Donor age less than 10 years
  • ✕Receiving concurrent solid organ or cell transplant (lung, heart, etc.)
  • ✕Positive T-cell lymphocytotoxic crossmatch
  • ✕Hepatitis B or C or HIV positive

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

Search/NCT00114777
NCT00114777Phase 3Completed
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Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

Bristol-Myers Squibb·interventional·Posted Jun 20, 2005·Updated Jul 7, 2017

In Brief

A Phase 3 clinical trial evaluating Cyclosporin A, Belatacept Less Intensive Regimen (LI), and 1 other intervention for Renal Transplantation. Completed, enrolled 595 participants across 79 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplantation
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hungary, Italy, Norway, Poland, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2005
Enrollment StartFeb 1, 2005
Primary CompletionMay 1, 2008
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 21.0 years ago

Interventions

Cyclosporin Adrug

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

Belatacept Less Intensive Regimen (LI)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 months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Belatacept More Intensive Regimen (MI)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, 5 mg/kg every 4 weeks, q 4 weeks, 84 months