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

Phase 4

Completed

• Conditions: Kidney Transplant; Complications; Kidney Transplant Rejection
• Interventions: Drug: Thymoglobulin; Drug: Basiliximab

• Registration Number: NCT03006419
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief Summary

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

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

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-30
• Status Verified: 2018-12
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B (Low-dose Thymoglobulin group)	Thymoglobulin	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.
Group A (Basiliximab group)	Basiliximab	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.

Primary Outcome Measures

Name	Time	Method
Biopsy proven acute rejection	12 months following transplantation	Acute rejection described by Banff category

Secondary Outcome Measures

Name	Time	Method
Patient survival	12 months following transplantation	Patient Death
Slow graft function	12 months following transplantation	Creatinine clearance \< 50% pretransplant during first week of transplantation
Delayed graft function	12 months following transplantation	Dialysis 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

Trial Locations

Locations (1)

Umae Hospital Especialidades 14 Adolfo Ruiz Cortines; 🇲🇽 Veracruz, Mexico