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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thymoglobulin Dose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3mg/kg Group

Patients will received Thymoglobuline 3mg/Kg (reduced dose)

Group Type EXPERIMENTAL

Thymoglobulin

Intervention Type DRUG

reduced dose (3mg/Kg)

6mg/kg Group

Patients will received Thymoglobuline 6mg/Kg (standard dose)

Group Type ACTIVE_COMPARATOR

Thymoglobulin

Intervention Type DRUG

reduced dose (3mg/Kg)

Interventions

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Thymoglobulin

reduced dose (3mg/Kg)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No