Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.

Study Overview

• Status: Unknown
• Conditions: Thymoglobulin Dose
• Intervention / Treatment: Drug: Thymoglobulin

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Ceará
    • Fortaleza, Ceará, Brazil, 60175-205
      • Transplant ward of the Hospital do Fortaleza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary kidney transplant recipients, adults

Exclusion Criteria:

• PRA > 50%
• DSA > 1500 MFI
• Retransplantation
• Patients who are planning to receive mycophenolate instead of everolimus
• Patients who have planning for follow-up in another center

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3mg/kg Group; Patients will received Thymoglobuline 3mg/Kg (reduced dose)	Drug: Thymoglobulin; reduced dose (3mg/Kg)
Active Comparator: 6mg/kg Group; Patients will received Thymoglobuline 6mg/Kg (standard dose)	Drug: Thymoglobulin; reduced dose (3mg/Kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute rejection	Biopsy proven and all treated acute rejection episodes	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	All infections requiring hospitalization	1 year

Collaborators and Investigators

• Sponsor: Hospital Geral de Fortaleza

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2015
• Primary Completion (Actual): January 10, 2018
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Thymoglobulin
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: patient data are confidential e will not be share with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No