drugset / Trial / NCT01608412
A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus
RandomizedParallel-groupOpen-labelPrevention
Summary
The study hypotheses to be tested in this study are: * Conversion to everolimus at 3 months post-transplantation is safe and effective; * Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients; * Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.
Timeline
- Start
- 2012-02
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Everolimus | Small molecule | — | — |
| Comparator | Tacrolimus | Small molecule | — | — |