Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00114777

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 III

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

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:	May 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

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:	February 2, 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 February 09, 2012