Efficacy of Integrated Risk Score Using Omics-Based Biomarkers for the Prediction of Acute Rejection in Kidney Transplantation: A Randomized Prospective Pilot Study

Author:

Lim Jeong-Hoon1ORCID,Chung Byung Ha2ORCID,Lee Sang-Ho3,Lee Jong Soo4ORCID,Kim Yeong Hoon5,Han Man-Hoon6,Jung Hee-Yeon1,Choi Ji-Young1ORCID,Cho Jang-Hee1ORCID,Park Sun-Hee1ORCID,Kim Yong-Lim1ORCID,Kim Chan-Duck1ORCID

Affiliation:

1. Division of Nephrology, Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu 41944, Republic of Korea

2. Division of Nephrology, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea

3. Division of Nephrology, Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul 02447, Republic of Korea

4. Division of Nephrology, Department of Internal Medicine, University of Ulsan College of Medicine, Ulsan 44033, Republic of Korea

5. Division of Nephrology, Department of Internal Medicine, College of Medicine, Inje University Busan Paik Hospital, Busan 47392, Republic of Korea

6. Department of Pathology, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu 41944, Republic of Korea

Abstract

Acute rejection (AR) is critical for long-term graft survival in kidney transplant recipients (KTRs). This study aimed to evaluate the efficacy of the integrated risk score of omics-based biomarkers in predicting AR in KTRs. This prospective, randomized, controlled, multicenter, pilot study enrolled 40 patients who recently underwent high-immunologic-risk kidney transplantation (KT). Five omics biomarkers were measured, namely, blood mRNA (three-gene signature), urinary exosomal miRNA (three-gene signature), urinary mRNA (six-gene signature), and two urinary exosomal proteins (hemopexin and tetraspanin-1) at 2 weeks and every 4 weeks after KT for 1 year. An integrated risk score was generated by summing each biomarker up. The biomarker group was informed about the integrated risk scores and used to adjust immunosuppression, but not the control group. The outcomes were graft function and frequency of graft biopsy. Sixteen patients in the biomarker group and nineteen in the control group completed the study. The mean estimated glomerular filtration rate after KT did not differ between the groups. Graft biopsy was performed in two patients (12.5%) and nine (47.4%) in the biomarker and control groups, respectively, with the proportion being significantly lower in the biomarker group (p = 0.027). One patient (6.3%) in the biomarker group and two (10.5%) in the control group were diagnosed with AR, and the AR incidence did not differ between the groups. The tacrolimus trough level was significantly lower in the biomarker group than in the control group at 1 year after KT (p = 0.006). Integrated omics biomarker monitoring may help prevent unnecessary or high-complication-risk biopsy and enables tailored immunosuppression by predicting the risk of AR in KTRs.

Funder

Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea

the National Research Foundation of Korea (NRF) funded by the Ministry of Education

Publisher

MDPI AG

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