A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
NCT ID: NCT00758602
Last Updated: 2014-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
210 participants
INTERVENTIONAL
2008-09-30
2011-02-28
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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MMF, Standard Dose Tacrolimus
Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.
mycophenolate mofetil
0.75-1 g PO BID from Day 0 through Month 12
tacrolimus, standard dose
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.
corticosteroids
According to center's practice
MMF, Low Dose Tacrolimus
Participants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 mg/kg, PO, BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to 0.05-0.08 mg/kg, PO, BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.
mycophenolate mofetil
0.75-1 g PO BID from Day 0 through Month 12
tacrolimus, low dose
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.
corticosteroids
According to center's practice
Interventions
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mycophenolate mofetil
0.75-1 g PO BID from Day 0 through Month 12
tacrolimus, standard dose
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.
tacrolimus, low dose
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.
corticosteroids
According to center's practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* single organ recipients of renal allograft;
* negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.
Exclusion Criteria
* severe infection, HIV or active hepatitis;
* active gastric ulcers;
* malignancy other than cured skin cancer;
* severe anemia, leucopenia or thrombocytopenia.
75 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Beijing, , China
Fuzhou, , China
Guangzhou, , China
Nanjing, , China
Shanghai, , China
Zhejiang, , China
Countries
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Other Identifiers
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ML21740
Identifier Type: -
Identifier Source: org_study_id
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