原発性IgA腎症患者におけるオープンラベルイプタコパン/LNP023の長期安全性および忍容性を評価するロールオーバー延長プログラム（REP）

基本情報

NCT ID

NCT04557462

ステータス

募集中

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

540

治験依頼者名

Novartis

概要

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

対象疾患

介入

依頼者（Sponsor）