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

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure

Intervention: Thymoglobulin (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Asan Medical Center


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death

Secondary outcome:

Pathologic findings according to Banff 2013 criteria

Overall rate of acute rejection

The rate of steroid-free immunosuppressive regimen


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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


- 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


- Pregnant women, nursing mothers, and women of childbearing potential who were not

using condoms or oral contraceptives

Locations and Contacts

Additional Information

Starting date: June 2015
Last updated: May 18, 2015

Page last updated: August 23, 2015

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