Transplant Immunology 78 (2023) 101802 Available online 1 March 2023 0966-3274/© 2023 Published by Elsevier B.V. Real-world data on renal transplantations from a tertiary-care hospital in North India, in context of Indian regulatory act-transplantation of human organs and tissues act (THOTA): A retrospective analysis Riya Bhargava, Rajni Chauhan * , Aseem Kumar Tiwari, Simmi Mehra, Swati Pabbi, Geet Aggarwal, Vishal Sharma, Vaishali Bhardwaj Molecular and Transplant Immunology Laboratory, Department of Transfusion Medicine, Medanta-The Medicity, Gurgaon, India A R T I C L E INFO Keywords: Renal transplant HLA THOTA Autosomal Mitochondrial Relationship Living donor transplantation ABSTRACT Introduction: Renal transplantation is the treatment of choice for patients suffering from end stage renal disease (ESRD). Indian regulations defned under Transplantation of Human Organs and Tissues Act (THOTA), 2014 restricts organ donations to near-related living donors to curb any malpractices like ‘paid donors’ in living-donor kidney transplantation (LDKT). The aim of our study was to look at real-world data of donor-recipient pairs and to identify relationship of donors (with their respective patients) and the common (or uncommon) DNA profling methods used for supporting “claimed relationship” in accordance with the regulations. Material and methods: The donors were categorized and grouped into near-related donor, donors other than near- related donors, swap donors and deceased donors. Claimed relationship was confrmed, commonly by HLA typing, using SSOP method. In few cases, which were uncommon (and infrequent), autosomal DNA analysis, mitochondrial DNA analysis and Y-STR DNA analysis were performed to support the claimed relationship. Data collected included age, gender, relationship, DNA profling test method. Results: Among the 514 donor-recipient pairs evaluated, numbers of female donors out-numbered male donors. The decreasing order of relationships in near-related donor group were wife- >mother>father>sister>son>brother>husband> daughter>grandmother. 11.9% of donors were in the cate- gory of donors other than near-related donors. In 97.86% cases, the claimed relationship was supported by HLA typing and in just 2.1% cases autosomal DNA analysis>mitochondrial DNA analysis> Y-STR DNA analysis, in this order, were performed to establish relationship. Conclusion: This study brought out gender disparity with women out-numbering men as donors. Among re- cipients, access to renal transplant was largely restricted to men. As far as relationship of donors to recipients was concerned, mostly near-related family members, like wife, were donors and claimed relationship was almost always (99%) was corroborated by HLA typing. 1. Introduction Diabetes mellitus and hypertension [1] are leading causes of end- stage renal disease (ESRD). Lifestyle disorders were reported for quite some time from countries with a high human development index (HDI). However, in the last few decades, an explosion of lifestyle-related dis- eases such as diabetes mellitus [3] and hypertension has occurred in medium HDI nations such as India [2,4]. Patients with long-standing diabetes mellitus and hypertension often develop nephropathy, result- ing in ESRD. The number of ESRD-related deaths in India rose from 0.59 million in 1990 to 1.18 million in 2016 [5], and presently, the burden of kidney failure deaths in India is considerably greater than that in other medium HDI countries with an identical or similar socio-demographic index [6]. Abbreviations: End-stage renal diseases, ESRD; Human Development Index, HDI; living-donor kidney transplantation, LDKT; Transplantation of Human Organs and Tissues Act, THOTA; deoxyribonucleic acid, DNA; human leukocyte antigen, HLA; molecular and transplant immunology, MTI; standard operating procedure, SOP; Hypervariable, HV’s; short tandem repeat, STR; chronic kidney disease, CKD; chronic obstructive pulmonary disease, COPD. * Corresponding author at: Molecular and Transplant Immunology Laboratory, Department of Transfusion Medicine, Medanta-The Medicity, Sector-38, Gurgaon 122001, India. E-mail address: rajnichauhan22@gmail.com (R. Chauhan). Contents lists available at ScienceDirect Transplant Immunology journal homepage: www.elsevier.com/locate/trim https://doi.org/10.1016/j.trim.2023.101802 Received 27 October 2022; Received in revised form 23 January 2023; Accepted 21 February 2023