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Trial record 1 of 1 for:    NCT00114777
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Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant (BENEFIT-EXT)

This study has been completed.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: June 17, 2005
Last updated: October 2, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Renal Transplantation
Drug: CsA
Drug: Belatacept LI
Drug: Belatacept MI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • subject and graft survival [ Time Frame: at 12 months ]
  • measured GFR and measured GFR change from baseline [ Time Frame: at 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 580
Study Start Date: February 2005
Study Completion Date: September 2014
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CsA Drug: 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: Bela LI Drug: 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: Bela MI Drug: 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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00114777

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Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information