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

NCT00270634 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	Aurinia Pharmaceuticals Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	334
Start date	2006-01
Completion	2009-07

Conditions

• Kidney Diseases

Interventions

• Voclosporin
• tacrolimus

Primary outcomes

• Biopsy Proven Acute Rejection (BPAR) — Six months
  The primary objective of the PROMISE trial was to demonstrate noninferiority of biopsy proven acute rejection (BPAR) rate in de novo renal transplant patients at 6 months in at least one VCS treatment group.

Countries

United States, Canada