NCT00270634

Study of ISA247 (Voclosporin) in De Novo Renal Transplantation

A Phase IIb, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 (Voclosporin) and Tacrolimus (Prograf®) in De Novo Renal Transplant Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Aurinia Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.

Detailed description

Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT). Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection. Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus

Conditions

• Kidney Diseases

Interventions

Type	Name	Description
DRUG	Voclosporin	voclosporin 0.4, 0.6, 0.8 mg/kg po BID
DRUG	tacrolimus	tacrolimus 0.05 mg/kg po BID

Timeline

• Start date: 2006-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2005-12-28
• Last updated: 2013-02-12
• Results posted: 2013-02-12

Locations

45 sites across 2 countries: United States, Canada