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

NCT ID: NCT02447822

Last Updated: 2015-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2018-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

6.0ATG

Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy

Group Type: ACTIVE_COMPARATOR

Thymoglobulin

Intervention Type: DRUG

6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

4.5ATG

Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy

Group Type: ACTIVE_COMPARATOR

Thymoglobulin

Intervention Type: DRUG

6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

Interventions

Thymoglobulin

6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Duck Jong Han

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 36857393 (View on PubMed)

Other Identifiers

AsanMC 2014-1213

Identifier Type: -

Identifier Source: org_study_id