Sirolimus-based, calcineurin inhibitor- free regimen in kidney transplant patients: An open-label, randomized, controlled trial
Amgad E. El-Agroudy 1 * , Sameer M. Al Arrayed 2, Sumaya M. Al-Ghareeb 2, Eman Farid 2, Hamad Alhelow 2, Sadiq Abdulla 2
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1 College of Medicine and Medical Sciences, Arabian Gulf University
2 Nephrology and Transplant Department, Salmaniya Medical Complex, Manama- Bahrain
* Corresponding Author


We report a prospective, open-label, randomized study to evaluate the safety and efcacy of converting patients with stable renal function from Tacrolimus (Tac)-based regimen to a Sirolimus (SRL)-based regimen after kidney transplantation.

Fifty eight low risk renal allograft recipients who were eligible to the study, 6 months posttransplant and receiving Tac, were randomly assigned to continue Tac (n=29) or convert to SRL (n=29). We evaluated the 3-year outcomes including patient and graft survival, graft function and safety profle.

3-year patient and graft survival in SRL and Tac groups was 93.1% vs. 100% (P=0.04), and 89.7% vs. 100% (P=0.04), respectively. However, the SRL group had signifcantly better renal function, from the second year post-transplant until the last follow-up. Four (13.8%) patients in the SRL group and 3 (10.3%) in the Tac group (P=0.5) developed biopsy proven acute rejection. Mean urinary protein excretion increased signifcantly after SRL conversion. Diastolic blood pressure was signifcantly lower in patients who eliminated tacrolimus (80.4 vs. 75.6 mmHg) (P = 0.03). Mean hemoglobin concentrations decreased after SRL conversion and remained signifcantly lower from 12 months to 36 months (P=0.01). The mean serum cholesterol and triglyceride levels increased signifcantly in the SRL group, (P < 0.05).

our experience demonstrates that conversion to sirolimus from calcineurin inhibitors (CNI)-based therapy may result in better renal function and blood pressure control in renal transplant recipients without an increased risk of acute rejection. However, these benefts have not resulted in a growing advantage in graft or patient survival.


This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Article Type: Original Article

EUR J GEN MED, 2016 - Volume 13 Issue 3, pp. 16-22

Publication date: 06 Aug 2016

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