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

Sponsor

Asan Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02447822

Collaborator

(none)

154

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure	Drug: Thymoglobulin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death [12 months after kidney transplantation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asan Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duck Jong Han, Professor, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT02447822

Other Study ID Numbers:

AsanMC 2014-1213

First Posted:

May 19, 2015

Last Update Posted:

May 19, 2015

Last Verified:

May 1, 2015

Additional relevant MeSH terms:

Renal Insufficiency

Thymoglobulin

Study Results

No Results Posted as of May 19, 2015