A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients
NCT ID: NCT00543569
Last Updated: 2015-12-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
323 participants
INTERVENTIONAL
2008-02-29
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tacrolimus/MMF/Basiliximab
Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
tacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
basiliximab
Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
mycophenolate mofetil
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
Corticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Alefacept QW/Tacrolimus/MMF
Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
Alefacept
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
tacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
mycophenolate mofetil
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
Corticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Alefacept QW/Tacrolimus
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
Alefacept
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
tacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
Corticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Alefacept QOW/Tacrolimus/MMF
Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
Alefacept
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
tacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
mycophenolate mofetil
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
Corticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Interventions
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Alefacept
Administered as a 7.5 mg intravenous bolus on day 0 (intraoperatively, prior to kidney revascularization) and Day 3; subsequently administered subcutaneously either weekly or every 2 weeks.
tacrolimus
The initial dose of tacrolimus was administered orally within 48 hours post-transplant. Subsequent doses were to be adjusted to achieve target whole blood trough concentrations.
basiliximab
Administered as a 20 mg bolus injection within 2 hours prior to transplantation and a 20 mg bolus injection on Day 3.
mycophenolate mofetil
Administered at 750 mg twice per day orally or intravenously for patients enrolled under Amendment 6 or earlier and at 1000 mg twice per day orally or intravenously for patients enrolled under Amendment 7. The dose of MMF could be adjusted based on clinical symptoms.
Corticosteroids
Corticosteroids were administered as a 500 to 1000 mg intravenous bolus on Day 0 and a 125 to 250 mg methylprednisone (or equivalent oral/intravenous corticosteroid dose) on Day 1. Oral prednisone was to be tapered per protocol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is a recipient of a de novo kidney transplant
* Subject is a recipient of a kidney from a non-human leukocyte antigen (HLA) identical related living donor, a non-related living donor, or a deceased donor
Exclusion Criteria
* Subject will receive a kidney with an anticipated cold ischemia time (CIT) of \> 30 hours
* Recipient has a positive T or B-cell cross match by investigational site's standard method of determination
* Subject will receive a kidney from a 50-65 year old deceased donor with one of the following:
* History of hypertension and a terminal serum creatinine \> 1.5 mg/dL
* Cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
* History of hypertension and cerebrovascular accident as cause of death and a terminal serum creatinine \> 1.5 mg/dL
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development
Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Loma Linda University Medical Center
Loma Linda, California, United States
University of Southern California - University Hospital
Los Angeles, California, United States
St. Vincent/National Institute of Transplantation
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
UCSD
San Diego, California, United States
California Institute of Renal Research/Sharp Memorial Hospital
San Diego, California, United States
University of California - San Francisco
San Francisco, California, United States
University of Colorado Health Science Center
Aurora, Colorado, United States
University of Florida, Shands Hospital, Gainesville
Gainesville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Medical College of Georgia, Augusta
Augusta, Georgia, United States
Rush - Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Buffalo General Hospital
Buffalo, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
New York Presbyterian Hospital - Cornell
New York, New York, United States
Westchester Medical Center
Valhalla, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospital of Cleveland
Cleveland, Ohio, United States
Legacy Transplant Services
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Pinnacle Health at Harrisburg
Harrisburg, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Methodist University Hospital - Memphis
Memphis, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Methodist Hospital Research Institute of Houston
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Countries
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Other Identifiers
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0485-CL-U201
Identifier Type: -
Identifier Source: org_study_id