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

Phase 4

• Conditions: Thymoglobulin Dose
• Interventions: Drug: Thymoglobulin

• Registration Number: NCT03088280
• Lead Sponsor: Hospital Geral de Fortaleza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-30
• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-17
• Study First Posted: 2017-03-23
• Primary Completion: 2018-01-10
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
6mg/kg Group	Thymoglobulin	Patients will received Thymoglobuline 6mg/Kg (standard dose)
3mg/kg Group	Thymoglobulin	Patients will received Thymoglobuline 3mg/Kg (reduced dose)

Primary Outcome Measures

Name	Time	Method
Acute rejection	1 year	Biopsy proven and all treated acute rejection episodes

Secondary Outcome Measures

Name	Time	Method
Infection	1 year	All infections requiring hospitalization

Trial Locations

Locations (1)

Transplant ward of the Hospital do Fortaleza; 🇧🇷 Fortaleza, Ceará, Brazil