JPRN-jRCT2080225066终止3 期
A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 850
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
- 年龄范围
- >= 12age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Male and female patients 12 =< age =< 70 upon study consent;
排除标准
- •-History of administration of polycystic kidney disease-modifying agents (somatostatin analogues) within 3 months prior to the Screen A visit;
- •-B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit;
- •-Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit;
- •-Serum albumin < 3 g/dL at Screen A visit;
- •-History of intracranial aneurysms;
- •-Kidney or any other solid organ transplant recipient or a planned transplant during the study;
- •-Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening;
- •-History of clinically significant left-sided heart disease and/or clinically significant cardiac disease;
- •-Systolic BP < 90 mm Hg at Screen A visit after a period of rest;
- •-BMI < 18.5 kg/m2 at the Screen A visit;
- •-History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas;
- •-Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study;
- •-Untreated or uncontrolled active bacterial, fungal, or viral infection;
- •-Participation in other interventional clinical studies within 30 days prior to Day 1;
- •-Unwilling to practice acceptable methods of birth control (both males who have partners of child-bearing potential and females of childbearing potential) during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested;
- •-Women who are pregnant or breastfeeding;
- •-Concomitant use of tolvaptan is excluded. Patients previously treated with tolvaptan must have discontinued drug for at least 3 months prior to Screen A visit
研究者
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