Autores
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Martinez-Mier, G, Moreno-Ley, PI, Budar-Fernandez, LF, Mendez-Lopez, MT, Barrera-Amoros, DA, De La Paz-Roman, M, Jimenez-Loez, LA, Aguilar-Sandoval, EG, Allende-Castellanos, CA -Más
Categoría
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Estudio primario
Año
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2019
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Purpose: Demonstrate that low dose Thymoglobulin (3 mg/kg total) has similar efficacy (DGF, SGF, BPAR, hospitalizations, adverse events, graft loss and death) than Basiliximab induction. Methods: Prospective randomized study of patients undergoing renal transplanta‐tion (NCT03006419). Inclusion Criteria: Graft recipients >18 years, first living donor kidney transplant. Exclusion Criteria: 2nd kidney transplant, multiple organ recipients, ABO incompatibility, positive cross‐match test prior to transplantation, PRA> 30%, positive DS A HIV, HBsAg or HCV positive patients, leukocyte count <2000/mm3, platelet count <75, 000/mm3, history of malignancy. 100 patients were randomized from 12/2016‐05/2018. Group A: Induction with Basiliximab 20 mg IV day 0 and day 4. Group B: rATG (Thymoglobulin) 1 mg/kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg/kg day. If WBC<2000/mm3 and/or platelets <75, 000/mm3), administration may be postponed until day 7 post‐transplant. Posttransplant immunosuppression: TAC, MMF and steroids. Outcome measures (12 months): DGF, SGF, BPAR, infections, adverse events, graft loss, death. EGFR was measured by MDRD. Results: Group A (Basiliximab) (n=53) had longer dialysis time than group B (Thymoglobulin) (n=47) (p<0. 05). ESRD etiology were similar in both groups. Both PRA were < 5% in both clases but class I was higher (s. s) in group B. Donor characteristics were similar between groups. [Table Presented] Mean Thymoglobulin dose was 3. 1 ± 0. 44 mg/kg. Initial TAC dose was 0. 07 ± 0. 07 mg/kg. All patients have completed six months follow‐up minimum. There were no differences in DGF, SGF and BPAR between groups. All BPAR were Banff IB. 3‐month TAC level and MMF dose was higher (s. s.) in Thymoglobulin group. No differences in EGFR AE, hospitalizations, patient and graft survival were noted between groups. [Table Presented] Conclusions: Our results suggest that 3mg/kg Thymoglobulin induction therapy has similar efficacy and safety outcomes than Basiliximab in low‐risk living donor kidney transplantation during follow‐up.
Epistemonikos ID: 710292340f6fa334a422bfbbaf9d4884ead0b993
First added on: Nov 24, 2021