drugset / Trial / NCT00087581
Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor (CNI), either cyclosporine or tacrolimus, in participants who have undergone kidney transplantation. Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI, concentration-controlled MMF with standard CNI, or fixed-dose MMF with standard CNI. Participants will be followed for 20-24 months after randomization.
Timeline
- Start
- 2004-06
- Primary completion
- 2007-09
- Completion
- 2007-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 100 mg | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 600 mg/m2 | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Subject | Tacrolimus | Small molecule | 1 mg | Oral |
| Subject | Tacrolimus | Small molecule | 5 mg | Oral |
Indications
No indication recorded.