Study Comparing the Safety and Efficacy of Belatacept (LEA29Y; BMS-224818) to Cyclosporine, in Patients Receiving a Kidney Transplant, When Used in Combination With CellCept, Simulect, and Corticosteroids. - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by (Responsible Party):	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035555

Purpose

The purpose of this study is to see if Belatacept (BMS-224818) treatment will be as efficacious as cyclosporine at preventing acute rejection, and a superior safety / tolerability profile (better kidney function, better blood pressure, less lipid problems, less diabetes mellitus, etc.)

Condition	Intervention	Phase
Graft Rejection Kidney Transplantation Renal Transplantation	Drug: Belatacept Drug: Cyclosporine	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 (Belatacept) as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Short-term: Incidence of clinically-suspected and biopsy-proven acute rejection (CSBPAR) of Belatacept versus CsA [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
Long-term: Safety and tolerability of Belatacept, in subjects who underwent a renal transplant [ Time Frame: Every year until Belatacept is marketed in the country where subjects are enrolled ] [ Designated as safety issue: Yes ]
Safety measured by Adverse events, clinically significant changes in vital signs or electrocardiograms (ECGs), laboratory test abnormalities, and clinical tolerability of the drug

Secondary Outcome Measures:

Short-term: Incidence of CSBPAR at 6 months or patient death or graft loss in subjects treated with Belatacept compared with subjects treated with CsA [ Time Frame: At 1 year ] [ Designated as safety issue: Yes ]
Short-term: Incidence of CSBPAR or presumed acute rejection in subjects treated with Belatacept compared with subjects treated with CsA [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: Yes ]
Short-term: Iohexol clearance in subjects treated with Belatacept compared with subjects treated with CsA [ Time Frame: At 1, 6 months and 1 year ] [ Designated as safety issue: Yes ]
Short-term: Blood pressure in subjects treated with Belatacept compared with subjects treated with CsA [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: Yes ]
Short-term: Serum cholesterol and triglycerides in subjects treated with Belatacept compared with subjects treated with CsA [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: Yes ]
Short-term: Overall safety in subjects treated with Belatacept compared with subjects treated with CsA [ Time Frame: At 6 months and 1 year ] [ Designated as safety issue: Yes ]
Safety measured by evaluation of adverse events, laboratory test results (hematology, biochemistry, and urinalysis), and changes in vital signs or physical examination results
Long-term: Efficacy of Belatacept, as compared to cyclosporin [ Time Frame: Every year until Belatacept is marketed in the country where subjects are enrolled ] [ Designated as safety issue: No ]
Efficacy is measured by the cumulative yearly incidence of biopsy-proven acute rejection (BPAR), clinically-suspected and biopsy-proven acute rejection (CSBPAR), chronic allograft nephropathy (CAN), calculations of glomerular filtration rate (GFR), serum creatinine, subject survival, and graft survival

Enrollment:	230
Study Start Date:	March 2001
Estimated Study Completion Date:	May 2012
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1: Belatacept more intensive (MI)	Drug: Belatacept Solution, Intravenous (IV), The MI regimen is designed to achieve projected serum trough concentrations of BMS-224818 of approximately 20 μg/mL through Day 99, and approximately 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, subjects in this group will be reallocated and dosed to achieve projected trough serum concentrations of either approximately 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197) Those subjects dose with belatacept every 8 weeks will receive placebo infusions on scheduled treatment dates between infusions of active drug in order to maintain the blind between treatment regimens Other Name: LEA29Y, BMS-224818
Experimental: Cohort 2: Belatacept less intensive (LI)	Drug: Belatacept Solution, Intravenous (IV), The LI regimen is designed to achieve projected trough serum concentrations of BMS-224818 of approximately 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects will be reallocated and dosed to achieve projected trough serum concentrations of either approximately 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113) Other Name: LEA29Y, BMS-224818
Experimental: Cohort 3: Cyclosporine (CsA)	Drug: Cyclosporine Oral, Capsule, Twice daily, designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose should be 7 ± 3 mg/kg. Subsequent doses should be adjusted to maintain a pre-defined range of serum concentrations: 1st month: target level 150-400 ng/mL After 1st month: target level of 150-300 ng/mL Other Name: The cyclosporine used in this study will be in the modified formulation with enhanced bioavailability (i.e., Neoral®)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Kidney transplant recipient

Exclusion criteria

human leukocyte antigen (HLA)-identical living-related donor/recipient pairs
active viral or bacterial infection
multiple organ transplant recipients
certain underlying causes of kidney failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035555

Locations

United States, California
Univ. of Calif. - San Francisco
San Francisco, California, United States, 94143-0001
United States, Georgia
Emory Univ. School of Medicine
Atlanta, Georgia, United States, 30322
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nebraska
Univ. of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-1002
United States, New Jersey
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029-6574
United States, Pennsylvania
Univ. of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical Univ. of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor Univ. Medical Center
Dallas, Texas, United States, 75246
United States, Wisconsin
Univ. of Wisconsin
Madison, Wisconsin, United States, 53792-7375

Sponsors and Collaborators

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
ClinicalTrials.gov Identifier:	NCT00035555 History of Changes
Other Study ID Numbers:	IM103-100
Study First Received:	May 3, 2002
Last Updated:	January 26, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

kidney
transplant
rejection

Additional relevant MeSH terms:

Cyclosporins
Cyclosporine
Abatacept
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents

Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012