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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Basiliximab vs Reduced Dose Rabbit Antithymocyte Globulin (rRTAG): Evaluation of Efficacy and Safety Outcomes in Low Immunological Risk Living Donor Kidney Transplant: 12-month Randomized Controlled Study

Conditions
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Kidney Transplant Rejection, Kidney Transplant; Complications

Intervention / Treatment
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* Drug: Basiliximab
* Drug: Thymoglobulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Basiliximab group)<br>Basiliximab (Simulect) induction therapy: 20 mg IV at day of transplant (to be administered 2 hours prior to transplant and up to 4 hours after transplant) and second dosage (20 mg) at fourth day after kidney transplantation. | Drug: Basiliximab<br>* Standard induction therapy<br>* Other names: Simulect;|
| Experimental: B (Low-dose Thymoglobulin group)<br>Thymoglobulin induction therapy (1 mg/kg rounded by 25 mg increments) at day of transplant followed by same dosage (1 mg/kg rounded by 25 mg increments) during day 1 and day 2 after transplant in order to complete 3 mg/kg accumulated dose. | Drug: Thymoglobulin<br>* Induction therapy<br>* Other names: rATG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy proven acute rejection | Acute rejection described by Banff category | 12 months following transplantation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, induction, thymoglobulin, basiliximab, acute rejection, graft loss