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- Title
Rabbit Anti-thymocyte Globulin (rATG) as Induction Immunosuppression Therapy in Patients Undergoing Renal Transplantation: Clinical Experience from RISE Registry.
- Authors
Ray, Deepak Shankar; Gang, Sishir; Khullar, Dinesh; Bhalla, Anil Kumar; Sharma, Ashish; Abraham, Abi; Raju, Sree Bhushan; Siddhi, Vishwanath; Dutta, Arup R.; Abraham, Georgie; Shekar, M. Soma; Shah, Bharat V.; Kothari, Jatin; Bahadur, Madan; Ahmed, Ishtiaque; Narula, Ajit Singh; Margabandhu, Sarvanan; Shetty, Sujatha; Chodankar, Deepa; Mandrekar, Aniket
- Abstract
Introduction: Induction immunosuppression therapy plays a significant role in the prevention of acute rejection in renal transplantation. This study aimed to evaluate the effectiveness and safety of rabbit anti‑thymocyte globulin (rATG) used as induction immunosuppression in Indian patients undergoing renal transplantation. Patients and Methods: RISE was a multicenter (n = 20), prospective observational cohort study of patients aged ≥ 18 years undergoing a first or repeat renal transplant and receiving rATG as part of the routine management practice. Twelve‑month acute rejection was evaluated as a primary endpoint. Results: A total of 325 patients were enrolled, of which 313 patients received at least one dose of rATG with a mean (standard deviation [SD]) duration of induction therapy of 2.07 (1.33) days. The mean (SD) cumulative rATG induction dose was 2.6 (1.5) mg/kg. The mean (SD) glomerular filtration rate was 64.59 (19.57) mL/min/1.73 m² at 6 months and 64.93 (20.26) mL/min/1.73 m² at 1 year. The incidence of acute rejection at 1 year was 7.7% (n = 23). Graft rejection at 6 months was observed in 6.7% (n = 20) patients and an average time to first graft rejection of 5.4 and 10.3 months at 6 and 12 months, respectively. In total, 342 adverse events (AEs) were reported (n = 154, 49.2%) after 12 months, of which 11 events were related to the rATG treatment. Pyrexia was the most commonly reported serious adverse event (n = 10, 3.2%). Seven deaths were reported during the study. Conclusions: The study revealed the effectiveness and safety of rATG induction therapy in the Indian context as expected based on the data from randomized clinical trials.
- Subjects
RESEARCH; GRAFT rejection; SCIENTIFIC observation; CONFIDENCE intervals; CLINICAL trials; IMMUNOSUPPRESSION; KIDNEY transplantation; ANTILYMPHOCYTIC serum; DESCRIPTIVE statistics; RESEARCH funding; DATA analysis software; PATIENT safety; LONGITUDINAL method
- Publication
Indian Journal of Transplantation, 2023, Vol 17, Issue 3, p294
- ISSN
2212-0017
- Publication type
Article
- DOI
10.4103/ijot.ijot_81_22