Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
- Sponsor
- Aurinia Pharmaceuticals Inc.
- Study ID
- NCT01586845
- Phase
- PHASE3
- Status
- Withdrawn
Conditions
- Renal Transplantation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- voclosporin — DRUGInitial dose of voclosporin 0.8 mg/kg BID, then concentration controlled
- tacrolimus — DRUGtacrolimus as per labeled dose
Study Details
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.
Key Dates
- Start date
- Mar 31, 2013
- Status verified
- Jan 2014
- Primary completion
- Dec 31, 2015
- Completion
- Dec 31, 2015
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: VoclosporinVoclosporin
- Active Comparator: TacrolimusTacrolimus
Primary Outcome Measure
The primary endpoint to assess non-inferiority will be efficacy failure at the end of Month 12 after randomization. [ Time Frame: 1 Year post-Transplant ]