NCT01586845

Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation

A Phase III, Randomized, Multicentre, Open-Label, Concentration-Controlled, Safety and Efficacy Study of Voclosporin and Tacrolimus in Renal Transplantation

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.

Detailed description

This will be a phase III, randomized, multicentre, open-label, concentration-controlled study in subjects undergoing a first or second renal transplant, with induction immunosuppression with an IL-2 receptor antibody (basiliximab), mycophenolate mofetil and steroids. The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	voclosporin	Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled
DRUG	tacrolimus	tacrolimus as per labeled dose

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-04-27
• Last updated: 2014-01-20