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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03088280

Enrollment

200

Registered

2017-03-23

Start date

2015-06-30

Completion date

2020-01-31

Last updated

2019-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thymoglobulin Dose

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.

Interventions

DRUGThymoglobulin

reduced dose (3mg/Kg)

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Infection	1 year	All infections requiring hospitalization

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026