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

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02447822
• Other study ID #: AsanMC 2014-1213
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 15, 2015
• Last updated: May 18, 2015
• Start date: June 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2015
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Drug:
• Thymoglobulin
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death		12 months after kidney transplantation	No
Secondary	Pathologic findings according to Banff 2013 criteria		1 day at the time of biopsy	No
Secondary	Overall rate of acute rejection		12 months after kidney transplantation	No
Secondary	The rate of steroid-free immunosuppressive regimen		12 months after kidney transplantation	No