The efficacy and safety of ciclosporin (Equoral®) capsules after renal transplantation: A multicentre, open-label, phase IV clinical trial.

Background: The use of bioequivalent generic ciclosporin is a cost-effective alternative to non-generic ciclosporin in renal transplant patients. This study aims to explore the efficacy, safety and tolerability of Equoral®, a generic ciclosporin, in adult de novo renal transplant patients.

Material/methods: This was a multicentre, open label, phase IV clinical study consisting of a 6-month treatment and 3-month follow-up periods. Patients underwent renal transplantation supported by an immunosupressive regimen of azathioprine (or mofetil mycophenylate [MMF]), prednisolone and Equoral® (10 mg/kg/day, given 12 hours before patients' surgical procedure, and a maintenance ciclosporin dose of 4-6 mg/kg/day thereafter). The primary endpoint was the rate of occurrence of acute graft rejection over the 6-month period after renal transplantation.

Results: A total of 54 patients were enrolled and constituted the intention-to-treat/safety population, while 52 patients forming the per-protocol population were assessed for efficacy. There were 13 episodes of acute graft rejection reported in 12 patients, and two of these episodes resulted in withdrawal from the study. The probability of acute rejection in patients was less then 24% for the duration of the study including the observation period which is within the usual range. There were no deaths and one graft loss during the study, and the safety and tolerability profile reported was typical of that of ciclosporin in use in de-novo renal transplant patients.

Conclusions: The use of the generic ciclosporin Equoral® is effective and is associated with the usual safety and tolerability profile of ciclosporin when used as the calcineurin-inhibitor component of an immunosuppressive regimen in de novo renal transplant patients.