Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients

Introduction: The TAILOR study in living donor kidney transplantation demonstrated a 98% one year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in 93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR rate in rATG (thymoglobulin) (p <0.05) and better serum creatinine in 3 and 5 years. The aim of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction.

Material and methods: Prospective randomized study of patients undergoing renal transplantation who wish to participate. 100 patients who meet the inclusion and exclusion criteria at the time of transplantation will be randomized

Experimental and reference therapy:

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. According to protocol administration, if there are conditions to delay administration (WBC<2000 / mm3 and / or platelets <75,000 / mm3) (17), administration may be postponed until day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and steroids

Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute rejection episodes infections hospitalizations adverse events graft loss death

• Basiliximab (Drug), also known as Simulect: Standard induction therapy
• Thymoglobulin (Drug), also known as rATG: Induction therapy

Primary outcomes

• Biopsy proven acute rejection [12 months following transplantation]: Acute rejection described by Banff category

Secondary outcomes

• Delayed graft function [12 months following transplantation]: Dialysis during first week of transplantation
• Slow graft function [12 months following transplantation]: Creatinine clearance < 50% pretransplant during first week of transplantation
• Infections [12 months following transplantation]: Presence of a positive culture of any microorganism in presence of clinical symptoms
• Hospital admissions [12 months following transplantation]: Admission to the hospital for at least 24 hours
• Graft function [12 months following transplantation]: Creatinine clearance measured by MDRD-4
• Graft loss [12 months following transplantation]: Return to dialysis
• Patient survival [12 months following transplantation]: Patient Death

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Male or female graft recipients older than 18 years of age.
* Informed consent to participate in the study.
* First living donor kidney transplant recipient.
* Negative pregnancy test if female participant

Exclusion Criteria:

* Second or more kidney transplant.
* Multiple organ transplant recipients.
* ABO incompatibility or positive cross-over test prior to transplantation.
* Antibody Reactive Panel (PRA) > 30%.
* Positive specific donor antibodies (DSA).
* Human immunodeficiency virus (HIV) positive patients.
* HBsAg or HCV positive.
* Severe lung disorders.
* Severe allergies receiving treatment that prevent patient's rRTAG administration.
* Leukocyte count below 2000 / mm3.
* Platelet count below 75,000 / mm3.
* History of malignant disease of any organ system (except skin basal cell carcinoma) within the last 5 years, regardless of local recurrence or metastasis.

• Laftavi MR, Alnimri M, Weber-Shrikant E, Kohli R, Said M, Patel S, Pankewycz O. Low-dose rabbit antithymocyte globulin versus basiliximab induction therapy in low-risk renal transplant recipients: 8-year follow-up. Transplant Proc. 2011 Mar;43(2):458-61. doi: 10.1016/j.transproceed.2011.01.035. PMID 21440733
• Schenker P, Ozturk A, Vonend O, Kruger B, Jazra M, Wunsch A, Kramer B, Viebahn R. Single-dose thymoglobulin induction in living-donor renal transplantation. Ann Transplant. 2011 Apr-Jun;16(2):50-8. doi: 10.12659/aot.881865. PMID 21716186
• Results publication: Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. doi: 10.1056/NEJMoa060068. PMID 17093248
• Results publication: Gaber AO, Matas AJ, Henry ML, Brennan DC, Stevens RB, Kapur S, Ilsley JN, Kistler KD, Cosimi AB; Thymoglobulin Antibody Immunosuppression in Living Donor Recipients Investigators. Antithymocyte globulin induction in living donor renal transplant recipients: final report of the TAILOR registry. Transplantation. 2012 Aug 27;94(4):331-7. doi: 10.1097/TP.0b013e31825a7d1f. PMID 22850297
• Results publication: Hardinger KL, Schnitzler MA, Koch MJ, Labile E, Stirnemann PM, Miller B, Enkvetchakul D, Brennan DC. Thymoglobulin induction is safe and effective in live-donor renal transplantation: a single center experience. Transplantation. 2006 May 15;81(9):1285-9. doi: 10.1097/01.tp.0000209825.91632.ea. PMID 16699456

• Gustavo Martinez-Mier, MD, Principal investigator, Jefe de División, UMAE 189, Veracruz, Veracruz