Clinical trial NCT00035555: Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft Rejection
Kidney Transplantation
Renal Transplantation
Keywords: kidney
transplant
rejection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-06
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)
timeFrame: By Month 6 posttransplant (From Day 1 to Month 6)
Secondary outcomes:
measure: Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12
timeFrame: Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)
measure: Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection
timeFrame: By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)
measure: Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)
timeFrame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
measure: Percentage of Participants Who Had Chronic Allograft Nephropathy
timeFrame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
measure: Mean Iohexol Clearance
timeFrame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
measure: Percentage of Participants Who Used Antihypertensive Medication
timeFrame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
measure: Number of Participants With Hypertension
timeFrame: By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)
measure: Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels
timeFrame: By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)
measure: Number of Participants With Posttransplant Diabetes Mellitus
timeFrame: By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )
Other outcomes:
measure: Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs
timeFrame: Day 1 (posttransplant) continuously to 56 days following last dose of study medication
measure: Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results
timeFrame: Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1)
Locations:
city: San Francisco
country: United States
facility: Univ. of Calif. - San Francisco
state: California
city: Atlanta
country: United States
facility: Emory Univ. School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Omaha
country: United States
facility: Univ. of Nebraska Medical Center
state: Nebraska
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: Univ. of Pennsylvania
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Univ. of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Baylor Univ. Medical Center
state: Texas
city: Madison
country: United States
facility: Univ. of Wisconsin
state: Wisconsin
Study officials:
References: