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
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Immunoglobulin A Nephropathy
- 发起方
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- 入组人数
- 600
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
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
结局指标
主要结局
未指定
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