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.
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035555
First received: May 3, 2002
Last updated: January 26, 2012
Last verified: January 2012
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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 2 |
| 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:
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:
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:
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 June 17, 2013