5-year follow-up of a randomized clinical study comparing everolimus plus reduced-dose cyclosporine with mycophenolate mofetil plus standard-dose cyclosporine in de novo kidney transplantation: Retrospective single center assessment.
Hiramitsu T, Okada M, et al.International Immunopharmacology 2016; 39: 192-198.
Aims
To evaluate the efficacy and safety of reduced dose cyclosporine plus everolimus, compared to standard cyclosporine plus mycophenolate mofetil after living donor kidney transplantation.
Interventions
Participants were randomized to receive twice-daily either reduced dose cyclosporine (3mg/kg) and everolimus (0.75mg) (EVR group), versus standard-dose cyclosporine (4 mg/kg) and mycophenolate mofetil (1000 mg) (STD group).
Participants
24 living donor kidney transplantation recipients.
Outcomes
The primary measured outcomes were estimated glomerular filtration rate and adverse events including de novo donor-specific antibody production, rejection, new-onset diabetes, hyperlipidemia, and cytomegalovirus infection.
Follow-up
5 years
CET Conclusions
This is a 5-year follow up of a RCT comparing everolimus plus low-dose cyclosporine with standard-dose cyclosporine plus mycophenolate mofetil with both groups receiving steroids and basiliximab. The study was conducted in 24 living-donor kidney transplant recipients and there were no missing data over 5 years. No information was included regarding randomisation and whether the allocation to groups was concealed, and the low number of participants is unlikely to provide sufficient power. At 1 and 5 years, there were no differences in eGFR, clinical or subclinical acute rejection, incidence of proteinuria, hyperlipidemia, or new-onset diabetes.
Data analysis
Strict intention-to-treat analysis
Trial registration
None