Back to resultsThymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)
Primary Purpose
Kidney Failure
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Thymoglobulin
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
6.0ATG
4.5ATG
Arm Description
Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy
Outcomes
Primary Outcome Measures
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
Secondary Outcome Measures
Pathologic findings according to Banff 2013 criteria
Overall rate of acute rejection
The rate of steroid-free immunosuppressive regimen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02447822
Brief Title
Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)
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 Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
6.0ATG
Arm Type
Active Comparator
Arm Description
Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
Arm Title
4.5ATG
Arm Type
Active Comparator
Arm Description
Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy
Intervention Type
Drug
Intervention Name(s)
Thymoglobulin
Intervention Description
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin
Primary Outcome Measure Information:
Title
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
Time Frame
12 months after kidney transplantation
Secondary Outcome Measure Information:
Title
Pathologic findings according to Banff 2013 criteria
Time Frame
1 day at the time of biopsy
Title
Overall rate of acute rejection
Time Frame
12 months after kidney transplantation
Title
The rate of steroid-free immunosuppressive regimen
Time Frame
12 months after kidney transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Thymoglobulin Induction Therapy in Kidney Transplantation (6mg/kg vs 4mg/kg)
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