NCT02447822

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Thymoglobulin	6.0 mg/kg vs 4.5 mg/kg Thymoglobulin

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-05-19
• Last updated: 2015-05-19