NCT01990118

Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Penang Hospital, Malaysia · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• End Stage Renal Failure

Interventions

Type	Name	Description
DRUG	Neoral	Neoral® capsule containing 25mg or 100mg cyclosporine
DRUG	Gengraf® capsule containing 25mg or 100mg cyclosporine	Transplant patients who were stable on Neoral were converted to Gengraf

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-12-01
• Completion: 2006-05-01
• First posted: 2013-11-21
• Last updated: 2013-11-21

Locations

1 site across 1 country: Malaysia