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

Sponsor:	Bristol-Myers Squibb
Information provided by:	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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
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: Cytotoxic T-lymphocyte antigen 4

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:	June 2010
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CsA: Active Comparator	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)
Bela LI: Experimental	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)
Bela MI: Experimental	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 105 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

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM103-008
Study First Received:	November 15, 2005
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00256750 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Renal Insufficiency
Immunologic Factors
Physiological Effects of Drugs
Kidney Failure, Chronic
Immunosuppressive Agents
Cytotoxic T-lymphocyte antigen 4
Pharmacologic Actions

Abatacept
Urologic Diseases
Renal Insufficiency, Chronic
Therapeutic Uses
Kidney Diseases
Antirheumatic Agents
Kidney Failure

ClinicalTrials.gov processed this record on February 08, 2010