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Shafiekhani, Mojtaba, Jafarzadeh, Mohammad Amin, Shahabinezhad, Farbod, Gholami, Siavash, Roozbeh, Jamshid, Zare, Zahra, Mohammadzadeh, Sahand, Doostfatemeh, Marziyeh, Nikeghbalian, Saman. (1405). A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients. سامانه مدیریت نشریات علمی, (), -. doi: 10.30476/ijms.2026.108281.4332
Mojtaba Shafiekhani; Mohammad Amin Jafarzadeh; Farbod Shahabinezhad; Siavash Gholami; Jamshid Roozbeh; Zahra Zare; Sahand Mohammadzadeh; Marziyeh Doostfatemeh; Saman Nikeghbalian. "A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients". سامانه مدیریت نشریات علمی, , , 1405, -. doi: 10.30476/ijms.2026.108281.4332
Shafiekhani, Mojtaba, Jafarzadeh, Mohammad Amin, Shahabinezhad, Farbod, Gholami, Siavash, Roozbeh, Jamshid, Zare, Zahra, Mohammadzadeh, Sahand, Doostfatemeh, Marziyeh, Nikeghbalian, Saman. (1405). 'A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients', سامانه مدیریت نشریات علمی, (), pp. -. doi: 10.30476/ijms.2026.108281.4332
Shafiekhani, Mojtaba, Jafarzadeh, Mohammad Amin, Shahabinezhad, Farbod, Gholami, Siavash, Roozbeh, Jamshid, Zare, Zahra, Mohammadzadeh, Sahand, Doostfatemeh, Marziyeh, Nikeghbalian, Saman. A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients. سامانه مدیریت نشریات علمی, 1405; (): -. doi: 10.30476/ijms.2026.108281.4332

A Retrospective Post-Marketing Surveillance Study on TGlobulin25®, the First Rabbit Anti-Thymocyte Globulin (r-ATG) Biosimilar Worldwide, as Induction Therapy in Adult Kidney Transplant Recipients

Iranian Journal of Medical Sciences
مقالات آماده انتشار، اصلاح شده برای چاپ، انتشار آنلاین از تاریخ 07 شهریور 1405    اصل مقاله (495.11 K)
نوع مقاله: Original Article(s)
شناسه دیجیتال (DOI): 10.30476/ijms.2026.108281.4332
نویسندگان
Mojtaba Shafiekhani1، 2؛ Mohammad Amin Jafarzadeh2؛ Farbod Shahabinezhad1؛ Siavash Gholami2؛ Jamshid Roozbeh3؛ Zahra Zare2؛ Sahand Mohammadzadeh4؛ Marziyeh Doostfatemeh5؛ Saman Nikeghbalian* 2
1Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran
2Shiraz Transplant Center, Abu-Ali Sina Hospital, Shiraz University of Medical Sciences, Shiraz, Iran
3Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
4Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
5Department of Biostatistics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
چکیده
Background: Post-marketing surveillance studies are essential to establish a realistic assessment of TGlobulin25®, the first rabbit anti-thymocyte globulin (rATG) biosimilar approved in Iran, for the prevention of acute kidney transplant rejection. This study aimed to conduct a post-marketing surveillance investigation comparing TGlobulin25® with the originator product regarding efficacy and safety in adult kidney transplant recipients.  
Methods: A comparative study of recipients who received either TGlobulin25® or Thymoglobulin® was conducted at the Abu-Ali Sina Transplant Center, Shiraz, Iran, from 21/03/2022 to 21/11/2022. Key outcomes, such as delayed graft function (DGF), biopsy-proven acute rejections, deaths, and adverse events, were assessed over a 1-year follow-up period. A multiple regression model was adjusted for confounding risk factors, and the normal distribution of continuous variables was evaluated using the Kolmogorov-Smirnov test.
Results: A total of 247 patients were enrolled (118 received TGlobulin25® and 129 received Thymoglobulin®). Except for the number of kidney transplantations, no statistically significant demographic differences were observed between the two groups. By the end of the study, DGF occurred in 19 patients (16.10%) in the TGlobulin25® group and 19 (14.72%) in the Thymoglobulin® group (P=0.76). Severe thrombocytopenia was reported in 
3 (2.54%) patients in the TGlobulin25® group and 5 (3.88%) in the Thymoglobulin® group (P=0.55), while severe leukopenia was reported in 15 (12.71%) and 7 (5.43%) patients, respectively (P=0.07). No significant difference was observed in biopsy-proven acute rejections (P=0.39), and no statistically significant risk factor for rejection was identified. Four patients in each group died (3.38% and 3.12%, respectively), and three cases of allograft nephrectomy were reported in the Thymoglobulin® group. No significant difference was found in serum creatinine and calculated eGFR, except for eGFR at the end of the 12th month (P=0.013). The risk of viral infections was also non-significant.
Conclusion: Overall, no statistically significant differences were observed in major efficacy and safety outcomes. However, eGFR at 12 months was higher in the TGlobulin25® group. The incidence of Leukopenia was non-significantly higher in the TGlobulin25® group.

تازه های تحقیق

Mojtaba Shafiekhani (Google Scholar)
Saman Nikeghbalian (Google Scholar)

کلیدواژه‌ها
Thymoglobulin؛ rabbit ATG؛ Kidney transplantation؛ Solid Organ Transplantation
مراجع
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