Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
NCT ID: NCT00113269
Last Updated: 2011-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
501 participants
INTERVENTIONAL
2005-05-31
2009-03-31
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
TREATMENT
NONE
Study Groups
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Alemtuzumab High-Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
tacrolimus
oral
alemtuzumab
Intravenous (IV)
mycophenolate mofetil
oral
steroids
IV and/or oral
Conventional High-Risk Patients
Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
rabbit anti-thymocyte globulin
IV
tacrolimus
oral
mycophenolate mofetil
oral
steroids
IV and/or oral
Alemtuzumab Low- Risk Patients
Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
tacrolimus
oral
alemtuzumab
Intravenous (IV)
mycophenolate mofetil
oral
steroids
IV and/or oral
Conventional Low-Risk Patients
Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American
basiliximab
IV
tacrolimus
oral
mycophenolate mofetil
oral
steroids
IV and/or oral
Interventions
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basiliximab
IV
rabbit anti-thymocyte globulin
IV
tacrolimus
oral
alemtuzumab
Intravenous (IV)
mycophenolate mofetil
oral
steroids
IV and/or oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patient receiving chronic steroid therapy at time of transplant
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Global Development
Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Livingston, New Jersey, United States
New Brunswick, New Jersey, United States
Hawthorne, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Harrisburg, Pennsylvania, United States
Charleston, South Carolina, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Countries
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References
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Hanaway MJ, Woodle ES, Mulgaonkar S, Peddi VR, Kaufman DB, First MR, Croy R, Holman J; INTAC Study Group. Alemtuzumab induction in renal transplantation. N Engl J Med. 2011 May 19;364(20):1909-19. doi: 10.1056/NEJMoa1009546.
Related Links
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Link to Prescribing Information
Other Identifiers
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20-04-003
Identifier Type: -
Identifier Source: org_study_id
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