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Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation — INSPIRE  

Renal Transplantation Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01586845
Study type Interventional
Source Aurinia Pharmaceuticals Inc.
Contact
Status Withdrawn
Phase Phase 3
Start date March 2013
Completion date December 2015
View Details
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