Overview

This trial is active, not recruiting.

Condition renal transplantation
Treatments csa, belatacept li, belatacept mi
Phase phase 3
Sponsor Bristol-Myers Squibb
Start date February 2005
End date May 2008
Trial size 600 participants
Trial identifier NCT00114777, IM103-027

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
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)
(Experimental)
belatacept 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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
(Experimental)
belatacept 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 (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)

Primary Outcomes

Measure
subject and graft survival
time frame: at 12 months
measured GFR and measured GFR change from baseline
time frame: at 12 months

Secondary Outcomes

Measure
biopsy proven chronic allograft nephropathy
time frame: by 12 months
post-transplant diabetes mellitus, hypertension and dyslipidemia
time frame: at 12, 24 and 36 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject is a first-time recipient of a kidney transplant from a deceased donor. - Specific donor criteria Exclusion Criteria: - Donor age <10 years - Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.) - Subjects with a positive T-cell lymphocytotoxic crossmatch. - Subjects who are positive for Hepatitis B or C, or HIV - Active TB - History of cancer in the last 5 years - History of substance abuse - Specific laboratory results are exclusionary - Mammography suspicious for cancer - Allergy to iodine - For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Additional Information

Official title Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.