drugset / Trial / NCT01023815

Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.

NCT01023815

Phase 3 Completed 330 enrolled Novartis
RandomizedParallel-groupOpen-labelPrevention

Summary

This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid withdrawal; C) everolimus, cyclosporine given twice a day and continuous steroids. The purpose of this study is to evaluate regimens A and B in comparison with the control group (group C) for efficacy, using as main endpoint the treatment failure rate, a composite endpoint including death, graft loss, BPAR and lost to follow-up between randomization and Month 12.

Timeline

Start
2009-04
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide
Subject Everolimus Small molecule Oral
Subject Prednisone Other / unclassified 5 mg Oral

Indications

No indication recorded.