NCT02267512

Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients

Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in de Novo Kidney Transplant Patients - a Multicenter, Randomized, Parallel Group Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.

Detailed description

To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in de novo kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate. The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function) and renal function

Conditions

• De Novo Kidney Transplant Patients

Interventions

Type	Name	Description
DRUG	ATG-F	Intravenous (IV)

Timeline

• Start date: 2012-07-31
• Primary completion: 2015-12-31
• Completion: 2015-12-31
• First posted: 2014-10-17
• Last updated: 2024-11-01

Locations

14 sites across 1 country: China