Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant (BENEFIT-EXT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00114777
First received: June 17, 2005
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
  • measured GFR and measured GFR change from baseline [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biopsy proven chronic allograft nephropathy [ Time Frame: by 12 months ] [ Designated as safety issue: No ]
  • post-transplant diabetes mellitus, hypertension and dyslipidemia [ Time Frame: at 12, 24 and 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2005
Estimated Study Completion Date: July 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114777

  Show 79 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00114777     History of Changes
Other Study ID Numbers: IM103-027
Study First Received: June 17, 2005
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 20, 2014