A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00455013
First received: March 30, 2007
Last updated: February 28, 2012
Last verified: February 2012
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Purpose
The purpose of this clinical research study is to learn if belatacept (BMS-224818) is expected to show acceptable rates of acute rejection (AR) in steroid-free belatacept-based immunosuppressive regiments compared to a similar steroid-free tacrolimus regimen. The long-term safety and tolerability of belatacept based regimens following long-term administration in subjects who have received a kidney transplant
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Transplantation |
Drug: Thymoglobulin Drug: Belatacept Drug: Sirolimus Drug: Tacrolimus Drug: Mycophenolate Mofetil (MMF) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized, Open-Label, Multicenter, Parallel-Group Study of Belatacept (BMS-224818)-Based Corticosteroid-Free Regimens in Renal Transplant |
Resource links provided by NLM:
Drug Information available for:
Mycophenolic acid
Mycophenolate sodium
Sirolimus
Tacrolimus
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Everolimus
Temsirolimus
Belatacept
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- AR rate in corticosteroid-free belatacept-based regimens [ Time Frame: 6 months post-transplantation ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- AR [ Time Frame: by 6/12 months ] [ Designated as safety issue: Yes ]
- Death/graft loss [ Time Frame: by 12 months ] [ Designated as safety issue: Yes ]
- AR/death/graft loss [ Time Frame: by 6 and 12 months ] [ Designated as safety issue: Yes ]
- Metabolic/cardiovascular (CV) comorbidity [ Time Frame: by 12 months ] [ Designated as safety issue: Yes ]
- Renal function [ Time Frame: by 12 months ] [ Designated as safety issue: Yes ]
- Corticosteroid-free subjects [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
- Treatment discontinuation [ Time Frame: by 12 months ] [ Designated as safety issue: Yes ]
- Safety and tolerability of different corticosteroid-free belatacept-based immunosuppressive regiments in subjects who have received a kidney transplant and completed 12 months of study treatment [ Time Frame: until month 36 ] [ Designated as safety issue: Yes ]
| Enrollment: | 93 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | May 2012 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Thymoglobulin
Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours
Drug: Belatacept
Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial
Other Name: BMS-224818
Drug: Mycophenolate Mofetil (MMF)
Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial
|
| Experimental: B |
Drug: Thymoglobulin
Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours
Drug: Belatacept
Belatacept arms will receive i.v. belatacept (10 mg/kg) on Days 1 and 5, and then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, and 12), and then every 4 weeks through Month 6 (Weeks 16, 20, and 24). After 6 months, subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial
Other Name: BMS-224818
Drug: Sirolimus
Sirolimus will be initiated at 5 mg/day on Day 1 (day of transplant) and continued through Day 2. The dosing will be adjusted subsequently to keep pre-dose (C0) levels at 7 - 12 ng/mL for the first 6 months, followed by 5 - 10 ng/mL thereafter
|
|
C
(IMPs as comparator regimen)
|
Drug: Thymoglobulin
Induction therapy, IV infusion, All subjects will receive thymoglobulin 1.5-mg/kg i.v. infusion on Days 1 (day of transplant), 2, 3, and 4 (up to a maximum total dose of 6 mg/kg) i.v. infusion over at least 4 hours
Drug: Tacrolimus
The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally up to and including week 52. Post week 52 subjects assigned to the tacrolimus arm will receive tacrolimus orally in accordance with local practice and the package insert until completion of the trial
Drug: Mycophenolate Mofetil (MMF)
Administered orally in a capsule or solution formulation in 2 divided doses on a consistent schedule in relation to time of day and meals. The dose should be 1 g bid; however 1.5 g bid may be administered at the investigator's discretion until completion of the trial
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Living or deceased donor renal allograft
- Men and women, 18 to 70 years old
- Subjects who have received a de novo kidney transplant, who have completed the initial study treatment through Month 12, and are willing to sign informed consent will be eligible to continue into the long term extension phase
Exclusion Criteria:
- Pregnant or breastfeeding women
- Epstein Barr Virus (EBV) negative serology
- First time renal transplant with panel reactive antibody (PRA) ≥ 50% or retransplantation with PRA > 30%
- Graft loss due to AR
- Positive T-cell or B-cell crossmatch
- Recipients/donors with HIV or hepatitis B/C
- Active tuberculosis (TB)
- Immunosuppressive therapy within 1 year of enrollment
- UNOS ECD organs will be excluded
- Body mass index (BMI) > 35 kg/m²
- Subjects who have developed any malignancy (other than non-melanoma skin cancer) or other medical condition that, in the investigator's opinion, should not be treated with an experimental immunosuppressive drug like belatacept
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455013
Locations
| United States, California | |
| Ucsf | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Denver Nephrology, Pc | |
| Denver, Colorado, United States, 80218 | |
| University Of Colorado Health Sciences Center | |
| Denver, Colorado, United States, 80262 | |
| United States, Georgia | |
| Medical College Of Georgia | |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Northwestern University Feinberg School Of Medicine | |
| Chicago, Illinois, United States, 60611 | |
| United States, Michigan | |
| Henry Ford Hospital | |
| Detriot, Michigan, United States, 48202 | |
| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| University Of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Italy | |
| Local Institution | |
| Bologna, Italy, 40138 | |
| Local Institution | |
| Brescia, Italy, 25123 | |
| Local Institution | |
| Padova, Italy, 35128 | |
| Local Institution | |
| Roma, Italy, 00168 | |
| Spain | |
| Local Institution | |
| Barcelona, Spain, 08907 | |
| Local Institution | |
| Sevilla, Spain, 41013 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00455013 History of Changes |
| Other Study ID Numbers: | IM103-034 |
| Study First Received: | March 30, 2007 |
| Last Updated: | February 28, 2012 |
| Health Authority: | United States: Food and Drug Administration Italy: C.E. A.O.S. ORSOLA-MALPIGHI Spain: Agencia Espanola de Medicamentos y Productos Sanitarios |
Keywords provided by Bristol-Myers Squibb:
|
Kidney transplant |
Additional relevant MeSH terms:
|
Mycophenolate mofetil Sirolimus Everolimus Tacrolimus Abatacept Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013