drugset / Trial / NCT00325325
Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus
Phase 2
Unknown
40 enrolled
Hospital Universitario Ramon y Cajal
Astellas Pharma Inc · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to address the pharmacokinetic (PK) profiles of everolimus and tacrolimus in combination in de novo kidney transplant recipients, comparing 1.5 and 3 mg per day of everolimus in fixed doses. For comparison purposes, pharmacokinetic profiles will be performed at first dose (abbreviated), 4th day, 14th day, and 42nd day post-transplantation.
Timeline
- Start
- 2006-01
- Primary completion
- —
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 0.75 mg | — |
| Subject | Everolimus | Small molecule | 1.5 mg | — |
| Subject | Tacrolimus | Small molecule | 0.15 mg/kg | — |