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

May 18, 2015 updated by: Duck Jong Han, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 6.0ATG
Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
Drug: Thymoglobulin
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin
Active Comparator: 4.5ATG
Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy
Drug: Thymoglobulin
6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death
Time Frame: 12 months after kidney transplantation
12 months after kidney transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Pathologic findings according to Banff 2013 criteria
Time Frame: 1 day at the time of biopsy
1 day at the time of biopsy
Overall rate of acute rejection
Time Frame: 12 months after kidney transplantation
12 months after kidney transplantation
The rate of steroid-free immunosuppressive regimen
Time Frame: 12 months after kidney transplantation
12 months after kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 15, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 19, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsanMC 2014-1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Failure

Clinical Trials on Thymoglobulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe