Safety and efficacy of everolimus in chronic allograft nephropathy

Abstract EN

Chronic allograft nephropathy (CAN) is a major cause of late kidney allograft loss.

Everolimus, a novel proliferation signal inhibitor, ameliorates CAN by its antiproliferative or apoptosis-enhancing effects.

This study aims to evaluate the safety and efficacy of everolimus in renal transplant recipients with calcineurin inhibitor (CNI) withdrawal either due to CAN or calcineurin inhibitor toxicity (CNIT).

A total 21 patients with CAN or CNIT converted from CNI to everolimus were prospectively studied from 2006 to 2009.

There were 19 males and two females, with a mean age of 32.9 ± 10.7 years.

Eight patients had chronic interstitial nephritis, three had diabetes mellitus, nine had end-stage renal disease and one had focal segmental glomerulosclerosis as native kidney disease.

The mean duration of dialysis was 10.7 ± 7 months.

57.2% of the patients had CAN and 42.8% had CNIT.

Everolimus was started within six months of posttransplantation in six patients, within 6–12 months in two patients, within 1–2 years in four patients and after more than 2 years in nine patients.

The mean dose at first month was 1.25 mg/day, at six month was 1.028 ± 0.3 mg/day and at 12th month was 0.97 ± 0.2 mg/day, with a mean trough level of 6.35 ± 3 ng/dL, 5.18 ± 3 ng/dL and 6.43 ± 1.7 ng/dL, respectively.

At the 12th month, serum creatinine declined from 2.07 ± 0.58 mg/dL to 1.65 ± 0.81 mg/dL.

The mean calculated glomerular filtration rate improved from 40.85 ± 8.8 mL/min to 56.84 ± 11.4 mL/min.

No major sideeffects were observed.

Everolimus along with mycophenolate mofetil or azathioprine and prednisolone as a maintenance immunosuppressive therapy was found to be effective and safe in patients with CNIs withdrawal either due to CAN or CNIT.