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

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00256750

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:

MedlinePlus related topics: Kidney Failure Kidney Transplantation

Drug Information available for: Belatacept

U.S. FDA Resources

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:	January 2006
Estimated Study Completion Date:	August 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

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

Show 107 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):

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.

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:	April 30, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Abatacept

Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012