drugset / Trial / NCT03099122

A Study of Thymoglobuline® Induction Therapy in Adult Recipients of Donated After Cardiac Death Kidney Transplant

NCT03099122

Phase 4 Completed 115 enrolled Sanofi
NaSingle-groupOpen-labelPrevention

Summary

Primary Objective: To investigate the efficacy of the standard dose of Thymoglobuline® induction therapy for preventing acute rejection (AR) after transplantation among recipients of Donated after Cardiac Death (DCD) kidney transplant. Secondary Objectives: * To evaluate delayed graft function (DGF), graft and patient survival after kidney transplant. * To evaluate adverse events of Thymoglobuline® throughout the study. * To explore possible risk factors of AR and DGF in patients with DCD kidney transplant. * To evaluate AR and DGF under different risk stratifications and explore an description optimal induction therapy regimen for recipients of DCD kidney transplant.

Timeline

Start
2017-08-16
Primary completion
2019-11-12
Completion
2019-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Thymoglobulin Protein / enzyme biologic Intravenous
Background Methylprednisolone Other / unclassified Intravenous
Background Mycophenolate Mofetil Small molecule Oral
Background Mycophenolate Na Unknown Oral
Background Prednisone Other / unclassified Oral
Background Tacrolimus Small molecule Oral