One-year multicenter double-blind randomized clinical trial on the efficacy and safety of generic cyclosporine (Iminoral) in de novo kidney transplant recipients.

Experimental & Clinical Transplantation [record in progress].

Aims
To evaluate the clinical outcomes of Iminoral consumption in renal transplant recipients one year after transplantation

Interventions
Patients were randomised to receive either Iminoral or Neoral.

Participants
221 de novo kidney transplant recipients.

Outcomes
The primary outcome was the rate of graft rejection occurrence during the first year after transplant. Secondary outcomes included graft loss, increase in daily doses of cyclosporine, decrease in trough and C2 cyclosporine blood levels, increase of serum creatinine levels, death rate, discontinuation of the study drug, tolerability and adverse events.

Follow-up
1 year

CET Conclusions
This study showed that the generic cyclosporin “Iminoral” was comparable to “Neoral” within a triple immune suppression regimen for de novo kidney transplant recipients. The rates of rejection free graft survival were comparable for the first year, as were data on renal function and adverse events. A large number of living donors were included which may affect the results. There was also no detailed explanation for the exclusion of 164 potential recipients from the study.

Jadad score
5

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT00656695

Funding source
Industry funded