drugset / Trial / NCT00170846

ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients

NCT00170846

Phase 4 Completed 394 enrolled Novartis Pharmaceuticals
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

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 3 mg
Subject Everolimus Small molecule 4 mg
Background Azathioprine Small molecule
Background Mycophenolate acid Unknown

Indications

No indication recorded.