Phase 2
N=218
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
Graft Rejection · Kidney Transplantation · Renal Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00035555 ↗Enrolled (actual)
218
Serious AEs
66.7%
Results posted
Jan 2014
Primary outcome: Primary: Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) — 5; 4; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Belatacept (Drug); Cyclosporine (Drug); Mycophenolate mofetil (MMF) (Drug); Corticosteroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Jan 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR) |
5; 4; 6 | — |
| SECONDARY Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12 |
14.9; 23.9; 17.8; 18.9; 29.6; 17.8 | — |
| SECONDARY Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection |
21.6; 29.6; 17.8; 23.0; 32.4; 24.7 | — |
| SECONDARY Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR) |
11; 9; 10; 11; 10; 11 | — |
| SECONDARY Percentage of Participants Who Had Chronic Allograft Nephropathy |
18.8; 9.1; 33.3; 28.8; 20.4; 44.4 | — |
| SECONDARY Mean Iohexol Clearance |
59.7; 60.2; 54.0; 62.2; 64.5; 56.0 | — |
| SECONDARY Percentage of Participants Who Used Antihypertensive Medication |
87.7; 78.6; 88.4; 24.7; 27.1; 21.7 | — |
| SECONDARY Number of Participants With Hypertension |
16; 15; 18; 14; 12; 11 | — |
| SECONDARY Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels |
129; 120; 137; 125; 121; 131 | — |
| SECONDARY Number of Participants With Posttransplant Diabetes Mellitus |
5; 0; 1; 0; 0; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00035555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.