Good Outcomes with Cyclosporine Very Low Exposure with Everolimus High Exposure in Renal Transplant Patients.

Journal of Nephrology, 24(5): 613-618, 2011.

Aims
To compare the efficacy of low exposure of cyclosporine (CsA) with high exposure of everolimus to standard exposure of CsA with enteric-coated mycophenolate sodium (EC-MPS) therapy in renal transplant patients.

Interventions
CsA (C2 250-300 ng/ml) with everolimus (C0 8-12 ng/ml) plus steroid versus CsA (C2 500-700 ng/ml) with enteric-coated mycophenolate sodium (1,440 mg/day) plus steroid. All patients received induction therapy with basiliximab.

Participants
106 renal transplant patients.

Outcomes
Biopsy-proven acute rejection (BPAR) rates, incidence of delayed graft function, one-year graft survival, estimated glomerular filtration rate (GFR); other outcomes included systolic blood pressure, hemoglobin blood level, serum cholesterol level and twenty-four hour proteinuria.

Follow-up
12 months

CET Conclusions
This single centre randomised trial compared low dose cyclosporine with high levels of everolimus plus steroids to normal dose cyclosporine with enteric coated EC-MPS plus steroids in a single centre trial of modest quality. There was a difference in estimated GFR but it has to be noted that the GRF was extraordinarily high in the everolimus arm, which may reflect the small sample size. Other features of interest were that there was a very high rate of proteinuria in the everolimus group and perhaps a modest improvement in systolic blood pressure in the everolimus group. There was a surprisingly low incidence of patient dropouts due to side effects in the everolimus arm. These results are of interest but a much larger and more rigorous trial would be needed to confirm the results reported in this study.

Jadad score
2

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
Not reported

Funding source
No funding received