drugset / Trial / NCT00154284

Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

NCT00154284

Phase 3 Completed 114 enrolled Novartis
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Timeline

Start
2005-07
Primary completion
2008-07
Completion
2008-07

Publications

  • Results Grinyo JM, Paul J, Novoa P, et al. (2010). Better renal function in renal-transplant recipients treated with everolimus plus cyclosporine elimination compared with cyclosporine minimisation, Am J Transplant; 10(Suppl 4): 503: Abstract 1636.

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide
Subject Everolimus Small molecule Oral
Background Basiliximab Monoclonal antibody
Background Prednisone Other / unclassified Intravenous