Kidney Failure
Conditions
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.
Interventions
DRUGThymoglobulin
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death | 12 months after kidney transplantation |
Secondary
| Measure | 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 |
Outcome results
None listed