Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)

Phase 4

• Conditions: Kidney Failure
• Interventions: Drug: Thymoglobulin

• Registration Number: NCT02447822
• Lead Sponsor: Asan Medical Center

Brief Summary

This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-05
• Study First Submitted: 2015-05-15
• Study First Submitted QC: 2015-05-18
• Last Update Submitted: 2015-05-18
• Study First Posted: 2015-05-19
• Last Update Posted: 2015-05-19
• Study Start: 2015-06
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Male or female patients with renal failure from 18 to 70 years of age
• Candidates for cadaveric or living donor kidney transplantation
• Patients who are able and willing to consent the protocol of the study

Exclusion Criteria

• Patients who have been receiving immunosuppressive therapy before transplantation
• Patients who have received an investigational medication within the past 30 days
• Patients who have a known contraindication to the administration of antithymocyte globulin
• Patients who are suspected or known to have an infection or were seropositive for hepatitis B surface antigen (HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Patients who have had cancer (except non melanoma skin cancer) within the previous 2 years
• Pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6.0ATG	Thymoglobulin	Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
4.5ATG	Thymoglobulin	Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy

Primary Outcome Measures

Name	Time	Method
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death	12 months after kidney transplantation

Secondary Outcome Measures

Name	Time	Method
Overall rate of acute rejection	12 months after kidney transplantation
Pathologic findings according to Banff 2013 criteria	1 day at the time of biopsy
The rate of steroid-free immunosuppressive regimen	12 months after kidney transplantation