腎移植患者における抗CD40モノクローナル抗体CFZ533の有効性、安全性、忍容性、薬物動態（PK）および薬力学（PD）に関する研究

基本情報

NCT ID

NCT03663335

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

418

治験依頼者名

Novartis

概要

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

対象疾患

介入

依頼者（Sponsor）