drugset / Trial / NCT01990118

Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

NCT01990118

Phase 4 Completed 106 enrolled Penang Hospital, Malaysia
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the standard treatment Neoral® for a treatment period of 6 months in stable renal allograft transplant recipients with respect to drug levels, dosage, and acute graft rejection and other adverse events.

Timeline

Start
2004-11
Primary completion
2005-12
Completion
2006-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 25 mg
Subject Cyclosporine Peptide 100 mg