Improved Renal Function After Early Conversion From a Calcineurin Inhibitor to Everolimus: a Randomized Trial in Kidney Transplantation.
Mjornstedt L, Sorensen SS, et al.American Journal of Transplantation [record in progress].
Aims
To evaluate whether early conversion from cyclosporine (CsA) to everolimus can improve long-term renal function in low- to medium-risk kidney transplant recipients.
Interventions
Conversion from CsA to everolimus 7 weeks after transplantation versus remaining on CsA. All patients received enteric-coated mycophenolate sodium and corticosteroids.
Participants
204 de novo kidney transplant recipients.
Outcomes
The primary efficacy endpoint was the change in renal function from week 7 to month 12, evaluated by measured glomerular filtration rates (GFR). Secondary endpoints included the occurrence of biopsy proven acute rejection, graft loss or death, percentage of patients receiving lipid-lowering drugs and antihypertensive medication, lipid profile and incidence of adverse event, serious adverse event and infections.
Follow-up
12 months
CET Conclusions
In these low risk recipients of a renal transplant conversion from CsA to everolimus 7 weeks after transplantation resulted in an improvement in the measured GFR of 4.9 ml/min by month 12. There was no difference in patient or graft survival but there was more biopsy proven acute rejection in the everolimus arm and more serious adverse events in the everolimus arm which resulted in discontinuation of everolimus in some 25 % of the patients. There was one case of tuberculosis but no transplant lymphoproliferative disorder.
Data analysis
Modified intention-to-treat analysis
Trial registration
NCT00634920 (ClinicalTrials.gov)