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

NCT02447822 | Unknown Phase 4

• 1 other identifier: AsanMC 2014-1213
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Failure

Outcome Measures

Primary Outcomes (1)

• A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death

  12 months after kidney transplantation

Secondary Outcomes (3)

• 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

Study Arms (2)

6.0ATG

ACTIVE COMPARATOR

Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy

Drug: Thymoglobulin

4.5ATG

ACTIVE COMPARATOR

Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy

Drug: Thymoglobulin

Interventions

Thymoglobulin DRUG

6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

4.5ATG; 6.0ATG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Related Publications (1)

• Ko Y, Wee YM, Shin S, Kim MJ, Choi MY, Kim DH, Lim SJ, Jung JH, Kwon H, Kim YH, Han DJ. A prospective, randomized, non-blinded, non-inferiority pilot study to assess the effect of low-dose anti-thymocyte globulin with low-dose tacrolimus and early steroid withdrawal on clinical outcomes in non-sensitized living-donor kidney recipients. PLoS One. 2023 Mar 1;18(3):e0280924. doi: 10.1371/journal.pone.0280924. eCollection 2023.

  PMID: 36857393 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

thymoglobulin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 19, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 19, 2015

Record last verified: 2015-05