ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1622702
Comparing Tacrolimus Level Monitoring in Peripheral Blood Mononuclear Cells and Whole Blood Within One Year After Kidney Transplantation: A Single-Center, Prospective, Observational Study
Provisionally accepted
Jia You1,2,3
Rui Chen2,4
Chai Yuhui2
Xue Wang2Wenmin Xie2
Yunyun Yang2Kaile Zheng1,2,3Lizhi Chen5
Zhuo Wang2*
Xuebin Wang1,2*- 1Shanghai Children's Hospital, Shanghai, China
- 2Shanghai Changhai Hospital, Shanghai, China
- 3Bengbu Medical University, Bengbu, China
- 4Children's Hospital of Fudan University, Shanghai, China
- 5Shanghai Altimetria Information Technology LLC, Shanghai, China
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Tacrolimus, a key immunosuppressant for kidney transplant recipients, is traditionally monitored through whole-blood trough concentrations. However, this approach may not accurately reflect lymphocyte tacrolimus levels, limiting its predictive value for allograft function and rejection. Monitoring tacrolimus levels in peripheral blood mononuclear cells (PBMCs) offers a potentially more precise alternative, though its clinical value remains unclear.This study aimed to compare tacrolimus intrapatient variability (IPV), allograft function, and de novo donor-specific anti-HLA antibody (dnDSA) status between PBMCbased and whole-blood tacrolimus monitoring methods to assess whether PBMC monitoring provides greater clinical utility. Methods This single-center, prospective, observational, non-interventional study enrolled kidney transplant recipients between November 2021 and February 2023. At six follow-up time points after transplantation (Day 7, Day 14, Month 1, Month 3, Month 6, and Month 12), tacrolimus levels in PBMCs and whole blood were measured, and IPVs in both matrices were calculated. Pearson's or Spearman's correlation analyses were used to evaluate (1) the relationship between tacrolimus levels in PBMCs and whole blood, (2) their association with allograft function, and (3) the correlation of tacrolimus IPV with allograft function and dnDSA status.A total of 60 kidney transplant recipients were included. Within one-year posttransplantation, the PBMC tacrolimus levels were 3.6% of whole-blood levels (P < 0.01). Tacrolimus levels in PBMCs and whole blood showed positive correlations across six-time points, with statistically significant correlations on Day 7, Day 14, Month 3, and Month 6 (P < 0.05). Notably, PBMC tacrolimus levels demonstrated stronger associations with creatinine clearance and estimated glomerular filtration rate at multiple timepoints compared to wholeblood measurements. Patients with dnDSA exhibited significantly higher intrapatient variability in PBMC tacrolimus levels than dnDSA-negative counterparts (P<0.05), a pattern not observed in whole-blood analysis.Monitoring tacrolimus levels and IPVs in PBMCs provides greater insight into allograft function and dnDSA status than whole-blood measurements. These findings suggest that PBMC-based tacrolimus monitoring may enhance clinical value in managing kidney transplant recipients.
Keywords: Kidney Transplantation, Tacrolimus, Intra-patient variability, peripheral blood mononuclear cell, Allograft function, De novo donor-specific antibody
Received: 04 May 2025; Accepted: 30 May 2025.
Copyright: © 2025 You, Chen, Yuhui, Wang, Xie, Yang, Zheng, Chen, Wang and Wang. 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:
Zhuo Wang, Shanghai Changhai Hospital, Shanghai, China
Xuebin Wang, Shanghai Children's Hospital, Shanghai, China
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