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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00256750
First received: November 15, 2005
Last updated: August 28, 2014
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Chronic Kidney Failure
Drug: CsA
Drug: Belatacept LI
Drug: Belatacept MI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy 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 (BENEFIT)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The composite of subject and graft survival [ Time Frame: by 12 months ] [ Designated as safety issue: No ]
  • The composite of measured GFR <60ml/min/1.73 m2 [ Time Frame: at Month 12 ] [ Designated as safety issue: No ]
  • A decrease in measured GFR >= 10mL/min/1.73m2 [ Time Frame: from Month 3 to Month 12 ] [ Designated as safety issue: No ]
  • The incidence of acute rejection [ Time Frame: by 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measured GFR [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Biopsy-proven chronic allograft nephropathy [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: March 2005
Estimated Study Completion Date: December 2014
Primary Completion Date: June 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 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 (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:

  • The subject is a recipient of a living donor or deceased donor kidney transplant.
  • Male or Female, 18 or older

Exclusion Criteria:

  • First time recipient, PRA >- 50% or for retransplantation PRA >- 30%.
  • If retransplantation, previous graft loss cannot be due to acute rejection.
  • Positive cross match.
  • Subject receiving extended criteria donor (ECD) organ
  • For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256750

  Show 105 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: NCT00256750     History of Changes
Obsolete Identifiers: NCT00432497
Other Study ID Numbers: IM103-008
Study First Received: November 15, 2005
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic

ClinicalTrials.gov processed this record on September 16, 2014