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

Sponsor

Coordinación de Investigación en Salud, Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT03006419

Collaborator

(none)

100

Enrollment

Location

Arms

31.9

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection Kidney Transplant; Complications	Drug: Basiliximab Drug: Thymoglobulin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Jul 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A (Basiliximab group) 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 Standard induction therapy Other Names: Simulect
Experimental: B (Low-dose Thymoglobulin group) 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 Induction therapy Other Names: rATG

Arm

Intervention/Treatment

Active Comparator: Group A (Basiliximab group)

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

Standard induction therapy

Other Names:

Simulect

Experimental: B (Low-dose Thymoglobulin group)

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

Induction therapy

Other Names:

rATG

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.