Therapeutic Kidney Donation: Historical Evolution, Scientific Rationale, and Early Outcomes of Clinical Trials in Japan
Received Date: Jan 01, 2026 / Published Date: Jan 29, 2026
Abstract
Objective: Kidney transplantation remains the optimal treatment for end-stage kidney disease; however, Japan faces a critical shortage of deceased-donor organs. Therapeutic Kidney Donation (TKD)—previously known as Restored Kidney Transplantation (RKT)—involves the transplantation of kidneys removed for the donor’s necessary medical treatment, specifically small renal tumors. This review examines the historical evolution of TKD, from its inception to current regulatory challenges in Japan.
Methods & Evidence: We analyzed international evidence regarding the oncologic safety of transplanting kidneys following the excision of small renal masses (<4 cm). We further reviewed the historical trajectory of the procedure in Japan, leading to its recent designation as an "Advanced Medical Technology," and evaluated early clinical outcomes from Japanese trials.
Results: International data consistently demonstrates negligible tumor recurrence rates when kidneys with small renal masses are resected with negative margins. In Japan, early clinical trials (2009–2017) involving both related and third-party donors showed excellent graft survival (functioning grafts >5 years) with no documented tumor transmission or recurrence.
Conclusion: With over 10,000 small renal masses treated annually in Japan, TKD represents a substantial, high-quality, and ethically grounded source of organs. Positioned alongside Expanded Criteria Donors (ECD) and Donation after Circulatory Death (DCD), TKD warrants further development to address the persistent organ shortage.
Citation: Ogawa Y, Kojima K, Kono Y (2026) Therapeutic Kidney Donation:Historical Evolution, Scientific Rationale, and Early Outcomes of Clinical Trials inJapan. J Clin Exp Transplant 11: 333.
Copyright: 漏 2026 Ogawa Y, et al. This is an open-access article distributed underthe terms of the Creative Commons Attribution License, which permits unrestricteduse, distribution, and reproduction in any medium, provided the original author andsource are credited.
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