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

• Status: Unknown status
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Thymoglobulin

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