Donor‐Derived Cell‐Free DNA for Diagnosing Subclinical Rejection: A Pilot Multicenter Study in Japanese Living‐Donor Kidney Transplantation
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| Format: | Artículo Open Access |
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Wiley
2025
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| author | Toshihito Hirai Taro Banno Kazuya Omoto Tomokazu Shimizu Sumi Hidaka Yu Kijima Miyuki Furusawa Ayaka Saitoh Kohei Unagami Masashi Inui Hideki Ishida Toshio Takagi |
| author_facet | Toshihito Hirai Taro Banno Kazuya Omoto Tomokazu Shimizu Sumi Hidaka Yu Kijima Miyuki Furusawa Ayaka Saitoh Kohei Unagami Masashi Inui Hideki Ishida Toshio Takagi Toshihito Hirai Taro Banno Kazuya Omoto Tomokazu Shimizu Sumi Hidaka Yu Kijima Miyuki Furusawa Ayaka Saitoh Kohei Unagami Masashi Inui Hideki Ishida Toshio Takagi |
| collection | Wiley Open Access |
| contents | Donor‐Derived Cell‐Free DNA for Diagnosing Subclinical Rejection: A Pilot Multicenter Study in Japanese Living‐Donor Kidney Transplantation Toshihito Hirai Taro Banno Kazuya Omoto Tomokazu Shimizu Sumi Hidaka Yu Kijima Miyuki Furusawa Ayaka Saitoh Kohei Unagami Masashi Inui Hideki Ishida Toshio Takagi Clinical Transplantation ABSTRACTBackgroundDonor‐derived cell‐free DNA (dd‐cfDNA) offers a non‐invasive biomarker for detecting allograft injury. However, its performance in predominantly living‐donor transplant settings in Asian populations remains underexplored.MethodsIn a multicenter prospective pilot study, 73 living‐donor kidney transplant (LKT) recipients from Japan underwent plasma dd‐cfDNA testing and protocol biopsies approximately 1 year post‐transplant. Diagnostic performance of dd‐cfDNA for subclinical antibody‐mediated rejection (AMR) was evaluated at 1.0% and 0.5% cut‐off thresholds.ResultsEight patients (11.0%) were diagnosed with subclinical active AMR. Patients with dd‐cfDNA ≥1.0% showed significantly higher incidence of AMR compared to those with dd‐cfDNA <1.0% (80% vs. 5.9%, p < 0.001). ROC analysis revealed an AUC of 0.85 for dd‐cfDNA in diagnosing AMR. Lowering the threshold to 0.5% improved sensitivity while maintaining high specificity. Patients with persistent donor‐specific antibodies (DSA) at 1‐year follow‐up exhibited significantly higher dd‐cfDNA levels. Neither HLA nor ABO incompatibility nor donor‐recipient relation significantly affected dd‐cfDNA levels.Conclusiondd‐cfDNA demonstrates high negative predictive value and complements DSA testing for early detection of subclinical AMR in living‐donor transplants. This pilot study provides foundational evidence for dd‐cfDNA‐based surveillance strategies in Asian cohorts. 10.1111/ctr.70221 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| doi_str_mv | 10.1111/ctr.70221 |
| format | Artículo Open Access |
| id | wiley_oa_10_1111_ctr_70221 |
| institution | Wiley Open Access |
| license_str_mv | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| publishDate | 2025 |
| publisher | Wiley |
| record_format | wiley_oa |
| spellingShingle | Donor‐Derived Cell‐Free DNA for Diagnosing Subclinical Rejection: A Pilot Multicenter Study in Japanese Living‐Donor Kidney Transplantation Toshihito Hirai Taro Banno Kazuya Omoto Tomokazu Shimizu Sumi Hidaka Yu Kijima Miyuki Furusawa Ayaka Saitoh Kohei Unagami Masashi Inui Hideki Ishida Toshio Takagi Clinical Transplantation Donor‐Derived Cell‐Free DNA for Diagnosing Subclinical Rejection: A Pilot Multicenter Study in Japanese Living‐Donor Kidney Transplantation Toshihito Hirai Taro Banno Kazuya Omoto Tomokazu Shimizu Sumi Hidaka Yu Kijima Miyuki Furusawa Ayaka Saitoh Kohei Unagami Masashi Inui Hideki Ishida Toshio Takagi Clinical Transplantation ABSTRACTBackgroundDonor‐derived cell‐free DNA (dd‐cfDNA) offers a non‐invasive biomarker for detecting allograft injury. However, its performance in predominantly living‐donor transplant settings in Asian populations remains underexplored.MethodsIn a multicenter prospective pilot study, 73 living‐donor kidney transplant (LKT) recipients from Japan underwent plasma dd‐cfDNA testing and protocol biopsies approximately 1 year post‐transplant. Diagnostic performance of dd‐cfDNA for subclinical antibody‐mediated rejection (AMR) was evaluated at 1.0% and 0.5% cut‐off thresholds.ResultsEight patients (11.0%) were diagnosed with subclinical active AMR. Patients with dd‐cfDNA ≥1.0% showed significantly higher incidence of AMR compared to those with dd‐cfDNA <1.0% (80% vs. 5.9%, p < 0.001). ROC analysis revealed an AUC of 0.85 for dd‐cfDNA in diagnosing AMR. Lowering the threshold to 0.5% improved sensitivity while maintaining high specificity. Patients with persistent donor‐specific antibodies (DSA) at 1‐year follow‐up exhibited significantly higher dd‐cfDNA levels. Neither HLA nor ABO incompatibility nor donor‐recipient relation significantly affected dd‐cfDNA levels.Conclusiondd‐cfDNA demonstrates high negative predictive value and complements DSA testing for early detection of subclinical AMR in living‐donor transplants. This pilot study provides foundational evidence for dd‐cfDNA‐based surveillance strategies in Asian cohorts. 10.1111/ctr.70221 http://onlinelibrary.wiley.com/termsAndConditions#vor |
| title | Donor‐Derived Cell‐Free DNA for Diagnosing Subclinical Rejection: A Pilot Multicenter Study in Japanese Living‐Donor Kidney Transplantation |
| topic | Clinical Transplantation |
| url | https://onlinelibrary.wiley.com/doi/10.1111/ctr.70221 |