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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: April 30, 2012
Last verified: December 2011
History of Changes

November 15, 2005
April 30, 2012
January 2006
June 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • The composite of subject and graft survival by 12 months.
  • The composite of measured GFR <60ml/min/1.73 m2 at Month 12 or a decrease in measured GFR >= 10mL/min/1.73m2 from Month 3 to Month 12.
  • The incidence of acute rejection by 12 months
Complete list of historical versions of study NCT00256750 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measured GFR at 12 months.
  • Biopsy-proven chronic allografnephropathy at 12 months.
 
 
 
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial (BENEFIT)

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.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Kidney Transplantation
  • Chronic Kidney Failure
  • 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)
  • 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)
  • 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)
  • Active Comparator: CsA
    Intervention: Drug: CsA
  • Experimental: Bela LI
    Intervention: Drug: Belatacept LI
  • Experimental: Bela MI
    Intervention: Drug: Belatacept MI
Vincenti F, Larsen CP, Alberu J, Bresnahan B, Garcia VD, Kothari J, Lang P, Urrea EM, Massari P, Mondragon-Ramirez G, Reyes-Acevedo R, Rice K, Rostaing L, Steinberg S, Xing J, Agarwal M, Harler MB, Charpentier B. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
660
August 2014
June 2008   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Mexico,   Poland,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey
 
NCT00256750
IM103-008
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
 
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP