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 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: August 28, 2014
Last verified: June 2013

June 17, 2005
August 28, 2014
February 2005
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00114777 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant
Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Renal Transplantation
  • 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)
  • 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)
  • 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
Pestana JO, Grinyo JM, Vanrenterghem Y, Becker T, Campistol JM, Florman S, Garcia VD, Kamar N, Lang P, Manfro RC, Massari P, Rial MD, Schnitzler MA, Vitko S, Duan T, Block A, Harler MB, Durrbach A. Three-year outcomes from BENEFIT-EXT: a phase III study of belatacept versus cyclosporine in recipients of extended criteria donor kidneys. Am J Transplant. 2012 Mar;12(3):630-9. doi: 10.1111/j.1600-6143.2011.03914.x. Epub 2012 Feb 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
November 2014
May 2008   (final data collection date for primary outcome measure)

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)
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,   Chile,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Norway,   Poland,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00114777
IM103-027
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2013

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