Comparison of Clinical Outcome of Induction Immunosuppressive Therapy With Thymoglobulin and Standard Therapy in Kidney Transplantation; a Randomized Double-Blind Clinical Trial Publisher



Shahbazian H¹ ; Ghorbani A¹ ; Hayati F¹ ; Beladi Mousavi SS^{1, 2} ; Sabetnia L¹ ; Ahmadi Halili S¹ ; Shayanpour S¹ ; Rezaee I¹ Show Affiliations
Source: Journal of Nephropathology Published:2020

Abstract

Introduction: Thymoglobulin is a lymphocyte-depleting polyclonal antibody, administered for induction therapy at the time of kidney transplantation to reduce the risk of acute allograft rejection. The appropriate dosage and duration of therapy is controversial. The higher dosages are associated with infection and malignancy. Objectives: In this study efficacy and safety of lower dosage (in comparison with previous studies) of thymoglobulin in kidney transplant recipients was evaluated. Patients and Methods: In this clinical trial, 106 adult kidney transplant recipients, were randomized before transplantation in two groups (case and control). The case group (53 patients) were received induction therapy with thymoglobulin (1.5 mg/kg/d for 3 days) and the control group (53 patients) were received non-induction regiment. Delayed graft function (DGF), glomerular filtration rate (GFR), acute allograft rejection and thymoglobulin complications were evaluated during the first post-transplantation year. Results: Around 106 kidney transplant recipients were enrolled (71 or 66.98% deceased donor) to the study. No significant statistical differences were found in GFR at the time of discharge from hospital (P = 0.399) and at 1 year (P = 0.851) and acute allograft rejection (P = 0.304) between two groups. Graft survival (73.5% in case group versus 81.1% in control group, P = 0.392) at month 12th was similar among groups. Additionally, no significant differences of acute allograft rejection in recipient from deceased or living donor between two groups were detected. There was a higher incidence of DGF in the control group (26.4%) than the thymoglobulin group (5.8%) and the difference was statistically significant (P = 0.004). Thrombocytopenia (17% versus 49.1%, P < 0.001) and leukopenia (11.3% versus 50.9%, P < 0.001) were also significantly higher in the case group. Conclusion: While the incidence of DGF was reduced in thymoglobulin group, the short-term acute allograft rejection rate was not reduced compared to the control group. However, our results require further consideration with larger samples. © 2020 The Author(s).