drugset / Trial / NCT02077556
Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.
Timeline
- Start
- 2014-04
- Primary completion
- 2019-01-15
- Completion
- 2019-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 1 mg | Oral |
| Comparator | Mycophenolate Mofetil | Small molecule | 10 mg/kg | Oral |
| Comparator | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.075 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | 20 mg | Intravenous |
| Background | Prednisolone | Other / unclassified | 20 mg | Oral |
Indications
No indication recorded.