TGlobulin 25 has demonstrated a favorable safety and efficacy profile in both preclinical (animal) and clinical (human) studies.
Preclinical Safety Studies
Study 1: A 14-day acute toxicity study comparing a control group to a group administered TGlobulin 25 revealed no adverse effects in any of the test animals.
Study 2: A 45-day sub-chronic toxicity study comparing TGlobulin 25 to a reference at comparable doses showed no significant differences in body weight, pathological findings, biochemical parameters, or food consumption between the control and treatment groups.
Clinical Safety and Efficacy Studies
Phase III Clinical Trial: Evaluation of the safety and efficacy of TGlobulin 25 compared to Thymoglobulin as induction therapy in kidney transplant recipients.
Patients were recruited from Dr. Shariati Hospital and Imam Khomeini Hospital, affiliated with Tehran University of Medical Sciences.
- Follow-up of patients was conducted 6 months post-transplant
- Patients were randomized into two groups for induction therapy post-renal transplantation
- The first group received TGlobulin 25 in combination with immunosuppressive agents
- The second group received Thymoglobulin in combination with immunosuppressive agents
No statistically significant differences were observed between TGlobulin25 and Thymoglobulin regarding safety and efficacy outcomes. Both groups demonstrated similar rates of mortality, CMV infection, adverse events such as infection, leukopenia, thrombocytopenia, fever, and thrombosis, as well as serious adverse events. Additionally, there were no significant differences in graft rejection, overall survival, delayed graft function (DGF), length of hospital stays, and reductions in lymphocyte counts and TCD3+ T cell markers between the two treatment groups.”
A phase IV post-marketing surveillance study to evaluate the safety of TGlobulin 25 and Thymoglobulin in transplant recipients
Patients from multiple hospitals in Shiraz, Mashhad, Isfahan, Urmia, Tabriz, and Ahvaz were enrolled in this study, with 304 receiving TGlobulin 25 and 350 receiving Thymoglobulin.
Incidence of venous thromboembolic events (VTE), pulmonary thromboembolism (PTE), renal vein thrombosis (RVT), deep vein thrombosis (DVT), disseminated intravascular coagulation (DIC), myocardial infarction (MI), nephrectomy, graft rejection, mortality, and delayed graft function (DGF) were compared between TGlobulin25 and Thymoglobulin recipients within one-month post-transplant. No statistically significant differences in safety and efficacy outcomes were observed between the two groups.
Furthermore, there were no significant differences between TGlobulin 25 and Thymoglobulin groups in terms of graft rejection, nephrectomy, mortality, and DGF. Additionally, the incidence of hematological adverse events was similar between the two groups.
Conclusion
The results of this study demonstrated a direct correlation between the incidence of post-kidney transplant thromboembolic events and the presence of underlying comorbidities known to be risk factors for these events, such as diabetes or a history of cardiac disease. These findings underscore the importance of initiating prophylactic anticoagulation therapy promptly post-transplant, regardless of the specific brand of rabbit anti-thymocyte globulin administered. Furthermore, no significant difference in dosing was observed between TGlobulin25 and Thymoglobulin. Additionally, the study revealed that the omission of heparin from TGlobulin25 infusion bags (when administered via peripheral vein) led to an increased incidence of thromboembolic events. Therefore, healthcare providers should strictly adhere to anticoagulant therapy guidelines.
