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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Kidney Failure

Intervention / Treatment
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* Drug: Thymoglobulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 6.0ATG<br>Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy | Drug: Thymoglobulin<br>* 6.0 mg/kg vs 4.5 mg/kg Thymoglobulin<br>|
| Active Comparator: 4.5ATG<br>Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy | Drug: Thymoglobulin<br>* 6.0 mg/kg vs 4.5 mg/kg Thymoglobulin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death |  | 12 months after kidney transplantation | 

Secondary Outcome Measures

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