ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Renal Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1631055
Comparison of the efficacy and safety of low-dose calcineurin inhibitors plus sirolimus plus mycophenolic acid with the standard-dose calcineurin inhibitors plus mycophenolic acid regimen in patients who received kidney transplants
Provisionally accepted
- 1Other
- 2The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
- 3Maoming People’s Hospital, Maoming, China
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Background: Sirolimus (SRL) has shown its anti-rejection and renoprotective efficacy in patients with kidney transplantation. However, more evidence is still needed. The current study aimed to evaluate the efficacy and safety of an SRL-containing regimen in patients who received kidney transplants. Methods: Fifty patients with end-stage renal disease who received kidney transplants were enrolled and divided into the calcineurin inhibitors (CNI) + mycophenolic acid (MPA)+ glucocorticoid (N=22) and CNI + MPA + SRL + glucocorticoid groups (N=28) according to the actual regimen that they received. The minimal plasma concentration of tacrolimus and cyclosporin was maintained at 6-10 ng/mL and 150-250 ng/mL in the CNI + MPA + glucocorticoid group and 4-6 ng/mL and 75-125 ng/mL in the CNI + MPA + SRL + glucocorticoid group. The minimal plasma concentration of SRL was maintained at 5-8 ng/mL. Results: The Cr at month (M)6, M12, and uric acid at M3 were lower, while the eGFR at M12 was higher in the CNI + MPA + SRL + glucocorticoid group compared with the CNI + MPA + glucocorticoid group (all P<0.05). The acute rejection rate showed a lower trend in the CNI + MPA + SRL + glucocorticoid group compared with the CNI + MPA + glucocorticoid group without statistical significance. The urine BK virus at M3, M6, M9, and M12 was lower in the CNI + MPA + SRL + glucocorticoid group compared with the CNI + MPA + glucocorticoid group (all P<0.05). Incidence of most adverse events was similar between groups, except that BK virus was lower in the CNI + MPA + SRL + glucocorticoid group compared with the CNI + MPA + glucocorticoid group (0.0% vs. 36.4%, P<0.01). Conclusion: Low-dose CNI combined with SRL regimen as the initial anti-rejection regimen indicates a comparable anti-rejection and better renoprotective efficacy with a satisfying safety profile compared with the standard regimen.
Keywords: calcineurin inhibitors, Sirolimus, Kidney transplant, Renoprotective, Safety
Received: 19 May 2025; Accepted: 22 Aug 2025.
Copyright: © 2025 Li, Wan, Li, Fang, Li, Ma and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Zheng Chen, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China
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