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

Hospital Geral de Fortaleza200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Thymoglobulin Dose

Interventions

ThymoglobulinDRUG

reduced dose (3mg/Kg)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Transplant ward of the Hospital do Fortaleza

Fortaleza, Ceará, Brazil

Outcomes

Primary Outcomes

Acute rejection

Biopsy proven and all treated acute rejection episodes

Time frame: 1 year

Secondary Outcomes

Infection

All infections requiring hospitalization

Time frame: 1 year

Data from ClinicalTrials.gov

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