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Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft Rejection; Kidney Transplantation; Renal Transplantation

Intervention: Belatacept (Drug); Cyclosporine (Drug); Mycophenolate mofetil (MMF) (Drug); Corticosteroids (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)

Secondary outcome:

Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12

Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection

Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)

Percentage of Participants Who Had Chronic Allograft Nephropathy

Mean Iohexol Clearance

Percentage of Participants Who Used Antihypertensive Medication

Number of Participants With Hypertension

Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels

Number of Participants With Posttransplant Diabetes Mellitus

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Key inclusion criteria

- Recipients of first kidney transplant

Key exclusion criteria

- Those at high risk for acute allograft rejection, including those who receive a

second or more renal transplant, those with a history of panel reactive antibody levels >20%, and those considered by investigators to be at relatively higher risk for acute rejection

- Human leukocyte antigen-identical donor-recipient pairs

- Cold ischemia time >36 hours (donor kidney)

- Participants who are positive for hepatitis C antibody, on polymerase chain reaction,

for hepatitis B surface antigen, and for human immunodeficiency virus

- A positive purified protein derivative tuberculosis test (test performed within 1

year of enrollment), unless previously vaccinated with Bacille-Calmette-Guérin or those who had a history of adequate chemoprophylaxis

- Any active infection that would normally exclude transplantation

- Recipients of multiple organ transplants

- Donor age >60 or <6 years or donors whose hearts were not beating

- Recipients with underlying renal disease of (due to risk of rapid disease recurrence

in the allograft): focal segmental glomerulosclerosis, Type I or II membranoproliferative glomerulonephritis, or hemolytic uremic syndrome/ thrombotic thrombocytopenic purpura

- A positive T-cell lymphocytoxic crossmatch using donor lymphocytes and recipient

serum

- A history of true allergy to intravenous iodinated roentgenographic contrast agents

- Participants with life expectancy severely limited by disease state or other

underlying medical condition

- A history of cancer (other than nonmelanoma skin cell cancers cured by local

resection) within the last 5 years

- Mammogram film with any clinically significant abnormality requiring further

investigation or biopsies

- History of substance abuse (drug or alcohol) or psychotic disorders that were not

compatible with adequate study follow-up

- A currently functioning, nonrenal transplant

- Previous treatment with basiliximab for any reason

- Active peptic ulcer disease, chronic diarrhea, or gastrointestinal malabsorption

- Those who had used any investigational drug within 30 days before the Day 1 visit.

Locations and Contacts

Univ. of Calif. - San Francisco, San Francisco, California 94143-0001, United States

Emory Univ. School of Medicine, Atlanta, Georgia 30322, United States

Johns Hopkins University, Baltimore, Maryland 21205, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Univ. of Nebraska Medical Center, Omaha, Nebraska 68198-1002, United States

Saint Barnabas Medical Center, Livingston, New Jersey 07039, United States

Mount Sinai Medical Center, New York, New York 10029-6574, United States

Univ. of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Medical Univ. of South Carolina, Charleston, South Carolina 29425, United States

Baylor Univ. Medical Center, Dallas, Texas 75246, United States

Univ. of Wisconsin, Madison, Wisconsin 53792-7375, United States

Additional Information

BMS Clinical Trials Disclosure

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

Starting date: March 2001
Last updated: November 27, 2013

Page last updated: August 23, 2015

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