drugset / Trial / NCT00170846
ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.
Timeline
- Start
- 2005-02
- Primary completion
- 2009-10
- Completion
- 2009-10
Outcome
Missed primary endpoint
registry Group A: No RAD vs Group B : CNI Withdrawal; p = 0.6332 NCT00170846 ↗
registry Group A: No RAD vs Group C: CNI Reduction; p = 0.7943 NCT00170846 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 3 mg | — |
| Subject | Everolimus | Small molecule | 4 mg | — |
| Background | Azathioprine | Small molecule | — | — |
| Background | Mycophenolate acid | Unknown | — | — |
Indications
No indication recorded.