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

A

Asan Medical Center

Status and phase

Unknown
Phase 4

Conditions

Kidney Failure

Treatments

Drug: Thymoglobulin

Study type

Interventional

Funder types

Other

Identifiers

NCT02447822
AsanMC 2014-1213

Details and patient eligibility

About

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.

Enrollment

154 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

154 participants in 2 patient groups

6.0ATG
Active Comparator group
Description:
Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy
Treatment:
Drug: Thymoglobulin
4.5ATG
Active Comparator group
Description:
Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy
Treatment:
Drug: Thymoglobulin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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