A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Summary
This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2008-09
- Primary completion
- 2011-02
- Completion
- 2011-02
Outcome
Missed primary endpoint
registry MMF, Standard Dose Tacrolimus vs MMF, Low Dose Tacrolimus; p = 0.0813; LS Mean difference 0.6581 (95% CI -0.08 to 1.40); ANCOVA NCT00758602 ↗
registry MMF, Standard Dose Tacrolimus vs MMF, Low Dose Tacrolimus; p = 0.7949; LS Mean difference -1.5977 (95% CI -13.77 to 10.58); ANCOVA NCT00758602 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 0.75 g | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Subject | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.08 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.15 mg/kg | Oral |
| Background | Corticosteroids | Unknown | — | — |
Indications
No indication recorded.