Study Evaluating Sirolimus in Kidney Transplant Recipients
NCT ID: NCT00195273
Last Updated: 2010-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2004-11-30
2008-07-31
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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1
Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
sirolimus
15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
mycophenolate mofetil
1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
corticosteroids
As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
daclizumab
IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
2
Cyclosporine + Mycophenolate + Corticosteroids
cyclosporine
Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
mycophenolate mofetil
1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
corticosteroids
As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
Interventions
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sirolimus
15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
cyclosporine
Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
mycophenolate mofetil
1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
corticosteroids
As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
daclizumab
IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
Eligibility Criteria
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Inclusion Criteria
* Donor must be at least 60 years old.
Exclusion Criteria
* Unstable angina or treatment for serious arrhythmia.
* Cancer within the previous 5 years.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor, MD
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Oslo, , Norway
Gothenburg, , Sweden
Uppsala, , Sweden
Countries
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Other Identifiers
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0468H-101466
Identifier Type: -
Identifier Source: org_study_id
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