Sirolimus monotherapy as maintenance immunosuppression: single-center experience in 50 kidney transplant patients

Chronic allograft nephropathy, cardiovascular mortality, and posttransplant malignancy are complications of conventional immunosuppression after kidney transplantation. We reported the feasibility of maintenance monotherapy with sirolimus (SRL) in a pilot experience. The aim was to study safety and feasibility of SRL maintenance monotherapy in 50 kidney transplant patients.

All patients from our center with at least 6 months follow-up on SRL monotherapy were included. During the first month after start of SRL monotherapy, follow-up visits were performed weekly, then each month for the following 2 months. Each follow-up visit included a physical exam and laboratory screening.

Mean follow-up on SRL monotherapy was 34.7 +/- 14.9 months. The time between transplantation until start of monotherapy was 7.7 +/- 3.3 years. No rejections occurred. During follow-up, two patients died of cardiovascular disease (already diagnosed before monotherapy); one, of previously diagnosed posttransplant malignancy and one, of hepatitis C-related liver failure. Glomerular filtration rate (GFR) was 53 mL/min x 1.73 m2 at start of monotherapy and 50 mL/min x 1.73 m2 after 4 years. Proteinuria was 632 +/- 562 mg/24 hours at 4 years. During the follow-up, no significant changes in the lipid profile, glycemia, or hemoglobin occurred.

Sirolimus monotherapy is safe in a selected group of immunological low-risk patients without increasing the risk of rejection.