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World J Transplant. Dec 18, 2025; 15(4): 107636
Published online Dec 18, 2025. doi: 10.5500/wjt.v15.i4.107636
Impact of cytochrome P450 3A5 expression on clinical outcomes in renal transplant recipients receiving tacrolimus-based immunosuppression
Amit S Pasari, Sunny Malde, Priyanka Tolani, Vishal Ramteke, Sushrut Gupta, Twinkle Pawar, Vijay Jeyachandran, Kapil Sejpal, Mohit Kurundwadkar, Prasad Gurjar, Pranjal Kashiv, Shubham Dubey, Charulata Bawankule, Vivek B Kute, Nishant Deshpande, Manish Ramesh Balwani
Amit S Pasari, Sunny Malde, Sushrut Gupta, Twinkle Pawar, Vijay Jeyachandran, Kapil Sejpal, Mohit Kurundwadkar, Prasad Gurjar, Pranjal Kashiv, Shubham Dubey, Manish Ramesh Balwani, Department of Nephrology, Jawaharlal Nehru Medical College, Wardha 442001, Maharashtra, India
Amit S Pasari, Charulata Bawankule, Manish Ramesh Balwani, Department of Nephrology, Saraswati Kidney Care Center, Nagpur 440015, Maharashtra, India
Priyanka Tolani, Department of Internal Medicine, Jawaharlal Nehru Medical College, Wardha 442001, Maharashtra, India
Vishal Ramteke, Nishant Deshpande, Department of Nephrology, Max Super Speciality Hospital, Nagpur 440030, Maharashtra, India
Vivek B Kute, Department of Nephrology, IKDRC-ITS, Ahmedabad 380016, Gujarat, India
Co-first authors: Amit S Pasari and Sunny Malde.
Co-corresponding authors: Vishal Ramteke and Priyanka Tolani.
Author contributions: Pasari AS, Tolani P, Ramteke V, Malde S, and Balwani MR designed the research study; Pasari AS, Malde S, Tolani P, and Ramteke V analysed the data and wrote the manuscript; Pasari AS, Malde S, Tolani P, Ramteke V, Gupta S, Pawar T, Jeyachandran V, Sejpal K, Kurundwadkar M, Gurjar P, Kashiv P, Dubey S, Bawankule C, Kute VB, Deshpande N, and Balwani MR contributed the patients for the study, and collected and analysed the data; all authors have read and approved the final manuscript.
Institutional review board statement: The study was reviewed and approved by the SKCC Institutional Ethics Committee Institutional Review Board (No. SKCC/IEC/2025/03/PN03)
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: All authors declare no conflict of interest in publishing the manuscript.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at vvramteke@gmail.com on request. Participants gave informed consent for data sharing.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Vishal Ramteke, MD, Department of Nephrology, Max Super Speciality Hospital, 232 Mankapur Koradi Road, Nagpur 440030, Maharashtra, India. vvramteke@gmail.com
Received: March 28, 2025
Revised: April 20, 2025
Accepted: June 4, 2025
Published online: December 18, 2025
Processing time: 236 Days and 15.3 Hours
Core Tip

Core Tip: This study evaluated the effect of cytochrome P450 3A (CYP3A)5 polymorphism on tacrolimus pharmacokinetics and clinical outcomes in renal transplant recipients. CYP3A5 expressors required significantly higher tacrolimus doses than non-expressors from 6 months onward to maintain therapeutic levels. Non-expressors consistently showed higher tacrolimus trough concentration (ng/mL)/daily tacrolimus dose (mg/kg/day) ratios, reflecting slower drug metabolism. Despite these differences, no significant impact was seen on acute rejection rates, renal function, or complications such as new onset diabetes after transplantation and hypomagnesemia. These findings emphasize the importance of genotype-guided tacrolimus dosing for individualized immunosuppressive management, while therapeutic drug monitoring helps mitigate clinical variability, ensuring comparable outcomes between expressors and non-expressors.