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

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 4

Conditions: Kidney Transplant; Complications; Kidney Transplant Rejection

Treatments: Drug: Thymoglobulin; Drug: Basiliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT03006419

R-2016-3001-61

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A (Basiliximab group)

Active Comparator group

Description:

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.

Treatment:

Drug: Basiliximab

B (Low-dose Thymoglobulin group)

Experimental group

Description:

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.

Treatment:

Drug: Thymoglobulin