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临床试验/SLCTR/2022/028
SLCTR/2022/028招募中2 期

Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy

Otsuka Pharmaceutical Development & Commercialization, Inc.0 个研究点目标入组 600 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
招募中
入组人数
600
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •1. Subjects who completed Trial 417-201-00007;NCT05248646 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201;NCT04287985 (at least 9 of the 12 doses and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN
  • •2.eGFR >20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

排除标准

  • •1.Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
  • •2.Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial

研究者

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