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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02447822
Recruitment Status : Unknown
Verified May 2015 by Duck Jong Han, Asan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 19, 2015
Last Update Posted : May 19, 2015
Information provided by (Responsible Party):
Duck Jong Han, 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.

Condition or disease Intervention/treatment Phase
Kidney Failure Drug: Thymoglobulin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 6.0ATG
Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
Drug: Thymoglobulin
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

Active Comparator: 4.5ATG
Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy
Drug: Thymoglobulin
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

Primary Outcome Measures :
  1. A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death [ Time Frame: 12 months after kidney transplantation ]

Secondary Outcome Measures :
  1. Pathologic findings according to Banff 2013 criteria [ Time Frame: 1 day at the time of biopsy ]
  2. Overall rate of acute rejection [ Time Frame: 12 months after kidney transplantation ]
  3. The rate of steroid-free immunosuppressive regimen [ Time Frame: 12 months after kidney transplantation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Duck Jong Han, Professor, Asan Medical Center Identifier: NCT02447822    
Other Study ID Numbers: AsanMC 2014-1213
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents