The PROMISE Study: A Phase 2b Multicenter Study of Voclosporin (ISA247) Versus Tacrolimus in De Novo Kidney Transplantation.
Busque S. Cantarovich M et al.American Journal of Transplantation, 11(12): 2675-2684, 2011.
Aims
To demonstrate noninferiority of Voclosporin in preventing acute rejection compared to tacrolimus after renal transplantation.
Interventions
Standard dose tacrolimus versus high dose Voclosporin versus medium dose Voclosporin versus low dose Voclosporin. All patients received induction immunosuppression with an anti-CD25 antibody, mycophenolate mofetil and steroids.
Participants
334 de novo renal transplant patients.
Outcomes
The primary outcome was biopsy proven acute rejection (BPAR) rate at 6 months. Secondary outcomes included patient and graft survival, a composite of BPAR, graft loss, death and lost to follow up. Safety outcomes included renal function, incidence of hypertension, hyperlipidemia, overall tolerability of Voclosporin and new-onset diabetes (NODAT). Other safety measures included incidence of (serious) adverse events, opportunistic infections and malignancies, vital sign measurements and electrocardiograph.
Follow-up
6 months
CET Conclusions
Voclosporin, a novel calcineurin inhibitor, appeared to be non inferior to tacrolimus in the prevention of biopsy proven acute rejection. Glomerular filtration rate was similar in all 3 dosing groups. There was no difference in the incidence of hypertension and adverse events, and possibly there was a reduced incidence of NODAT.
Data analysis
Strict intention-to-treat analysis
Trial registration
NCT00270634 (ClinicalTrials.gov)