Study Comparing the Safety and Efficacy of BMS-224818 to Cyclosporine, in Patients Receiving a Kidney Transplant, When Used in Combination With CellCept, Simulect, and Corticosteroids.

This study has been completed.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035555

Purpose

The purpose of this study is to see if 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: LEA29Y, Belatacept	Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Abatacept Basiliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II/III, Open-Label, Randomized, Controlled, Multiple-Dose Study of Efficacy and Safety of BMS-224818 as Part of a Quadruple Drug Regimen in First Renal Transplant Recipients

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To obtain long-term safety and efficacy of Belatacept, in subjects who underwent a renal transplant, until Belatacept is marketed in the individual countires where the subjects are enrolled. [ Time Frame: Data will be reviewed on a yearly basis ]

Secondary Outcome Measures:

To compare safety, efficacy and tolerability of Belatacept, as compared to cyclosporin. [ Time Frame: Data will be reveiwed on a yearly basis. ]

Estimated Enrollment:	400
Study Start Date:	March 2001

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

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

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

Study ID Numbers:	IM103-100
Study First Received:	May 3, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00035555
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

kidney
transplant
rejection

Study placed in the following topic categories:

Basiliximab
Abatacept
Cyclosporine
Mycophenolate mofetil
Cyclosporins

ClinicalTrials.gov processed this record on January 16, 2009