Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

End Stage Renal Failure Clinical Trial

Official title: A Randomized, Multi-center, Open Label Trial to Establish the Therapeutic Equivalence Between Neoral® and Gengraf® in Stable Renal Allograft Recipients [Gengraf Conversion Study]

Status Completed

Clinical Trial 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.

Clinical Trial Description

The introduction of cyclosporine (CsA) into clinical practice resulted in improvements in acute renal allograft rejection rate and graft survival in renal transplant patients. Gengraf a microemulsion formulation of CsA though granted an AB-rated equivalent to Neoral, because of concerns over the use of generic drugs in transplantation, we undertook this study to evaluate the clinical efficacy and safety of Gengraf.

We conducted a multicenter, randomized, open labeled study to establish the equivalence between Gengraf and Neoral in stable renal transplant recipients for a treatment period of 6 months. 6 months post transplant patients with stable graft function and receiving a stable dose of neoral were recruited into the study. Eligible patients were randomly assigned to remain on Neoral or convert to an equal milligram-for-milligram dose of Gengraf. The primary end-point was serum creatinine at 26 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Failure
• Kidney Failure, Chronic

• NCT number: NCT01990118
• Study type: Interventional
• Source: Penang Hospital, Malaysia
• Status: Completed
• Phase: Phase 4
• Start date: November 2004
• Completion date: May 2006