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
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.
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 criteriaOverall rate of acute rejection The rate of steroid-free immunosuppressive regimen
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2015
Last updated: May 18, 2015
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