drugset / Trial / NCT00284934
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.
Timeline
- Start
- 2005-12
- Primary completion
- 2008-06
- Completion
- 2008-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tacrolimus | Small molecule | — | Oral |
| Subject | mycophenolic acid | Small molecule | 720 mg | Oral |
| Subject | mycophenolic acid | Small molecule | 1440 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |