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: April 30, 2012

Last verified: December 2011

History of Changes

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:

MedlinePlus related topics: High Blood Pressure Kidney Transplantation

Drug Information available for: Belatacept

U.S. FDA Resources

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 80 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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:	April 30, 2012
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 May 19, 2013

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