Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE2
260 participants
INTERVENTIONAL
2008-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: Basiliximab+Belatacept (MI) + MMF
Belatacept More Intensive (MI)
Intravenous (IV),
10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.
After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\])
Basiliximab
Intravenous (IV), 20 mg, Day1 and Day 5
Mycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Group 2: Belatacept (MI) + MMF
Belatacept More Intensive (MI)
Intravenous (IV),
10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.
After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\])
Mycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Group 3: Belatacept Less Intensive (LI) + MMF
Belatacept Less Intensive (LI)
Intravenous (IV),
10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.
After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)
Mycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Group 4: Tacrolimus + MMF
Other
Tacrolimus
Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\])
Mycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Group 5: Tacrolimus
Tacrolimus
Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\])
Interventions
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Belatacept More Intensive (MI)
Intravenous (IV),
10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24.
After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\])
Tacrolimus
Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\])
Basiliximab
Intravenous (IV), 20 mg, Day1 and Day 5
Belatacept Less Intensive (LI)
Intravenous (IV),
10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12.
After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)
Mycophenolate Mofetil (MMF)
Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])
Eligibility Criteria
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Inclusion Criteria
* Age 18-70
* Hepatitis C virus (HCV) positive recipients
* For Long-term extension study-Subjects who have completed one year of study treatment (through Week 52)
Target Disease Exclusions:
Donor Exclusions a) Living donors b) ABO-incompatible donor recipient pairs c) Donor age \< 12 or \> 65 years d) Non heart-beating donors e) Anticipated cold ischemia time \> 14 hours f) Donor Disease i) Known Human immunodeficiency virus (HIV) infection ii) Hepatitis B virus (HBV) surface antigen-positive or polymerase chain reaction (PCR)-positive donor if HBV negative recipient iii) HCV antibody-positive or PCR positive donor if HCV negative recipient
Recipient Exclusions g) Subjects with a history of hypercoagulable state h) Subjects with fulminant hepatic failure i) Subjects receiving a split or reduced liver j) Subjects who are Epstein-Barr virus (EBV) negative
Medical History and Concurrent Diseases
1. Subjects who have received 2 or more consecutive weeks of dialysis 1 month prior to enrollment OR anticipated to have prolonged dialysis post-transplantation
2. Subjects with known intrinsic renal disease (e.g., a urine protein/ creatinine ratio \> 150 mg/g or the presence of an abnormal number of red blood cells (RBCs) or granular casts in the urine) AND calculated GFR \< 40 ml/min/1.73 m\^2 body surface area (BSA) (abbreviated Modification of Diet in Renal Disease \[MDRD\]). Subjects must have a calculated GFR assessment within 1 month prior to enrollment.
3. Subjects with known HIV
4. Subjects with any prior or concurrent solid organ (e.g., heart, kidney, pancreas) or cell (e.g., islet, bone marrow) transplant or subjects deemed likely to have a second solid organ or cell transplant (e.g., islet, bone marrow) within the next 3 years.
5. Subjects with a history of cancer within the last 5 years
Allergies and Adverse Drug Reactions
a) Hypersensitivity to any medications that will be used in the protocol
Prohibited Treatments and/or Therapies
1. Subjects receiving immunosuppressive agent(s) (e.g., methotrexate, abatacept, infliximab, etanercept, chemotherapy, etc.) within the past 6 months for other indications such as an autoimmune disease
2. Subjects who received maintenance corticosteroids at a dose of \> 5 mg/day of prednisone (or equivalent) for at least 7 consecutive days within the prior year for an underlying chronic inflammatory or autoimmune disease
3. Subjects who have used any investigational drug within 30 days prior to the Day 1 visit
4. Subjects previously treated with belatacept
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Usc University Hospital
Los Angeles, California, United States
University Of California San Francisco Medical Center
San Francisco, California, United States
Mayo Clinic Transplant Department
Jacksonville, Florida, United States
Lifelink Healthcare Institute
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States
Tulane Center For Abdominal Transplant
New Orleans, Louisiana, United States
Henry Ford Hospital
Detriot, Michigan, United States
University Of Minnesota
Minneapolis, Minnesota, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Nyu School Of Medicine
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Univ. Of Cin. Coll. Of Med.
Cincinnati, Ohio, United States
Integris-Baptist Medical Ctr.
Oklahoma City, Oklahoma, United States
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Local Institution
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution
Vienna, , Austria
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Rio de Janeiro, Rio de Janeiro, Brazil
Local Institution
Centro-Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
Edmonton, Alberta, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Clichy, , France
Local Institution
Lyon, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Toulouse, , France
Local Institution
Villejuif, , France
Local Institution
Berlin, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Hanover, , Germany
Local Institution
Heidelberg, , Germany
Local Institution
Tübingen, , Germany
Local Institution
Bergamo, , Italy
Local Institution
Padua, , Italy
Local Institution
Pisa, , Italy
Local Institution
Roma, , Italy
Local Institution
Barcelona, , Spain
Countries
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References
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Klintmalm GB, Feng S, Lake JR, Vargas HE, Wekerle T, Agnes S, Brown KA, Nashan B, Rostaing L, Meadows-Shropshire S, Agarwal M, Harler MB, Garcia-Valdecasas JC. Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study. Am J Transplant. 2014 Aug;14(8):1817-27. doi: 10.1111/ajt.12810.
Other Identifiers
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IM103-045
Identifier Type: -
Identifier Source: org_study_id