JPRN-UMIN000032448已完成未知
A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Alport Syndrome - CARDINA
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 187
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
- 12years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Prior exposure to bardoxolone methyl 2. Ongoing chronic hemodialysis or peritoneal dialysis therapy 3. Renal transplant recipient 4. B-type natriuretic peptide (BNP) level > 200 pg/mL at Screen A visit 5. Uncontrolled diabetes (HbA1c > 11.0%) at Screen A visit 6. Acute dialysis or acute kidney injury within 12 weeks prior to Screen A visit or during Screening 7. Serum albumin < 3 g/dL at Screen A visit 8. History of clinically significant left-sided heart disease and/or clinically significant cardiac disease 9. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Screen A visit after a period of rest 10. Systolic BP < 90 mm Hg at Screen A visit after a period of rest 11. History of malignancy within 5 years prior to Screen A visit, with the exception of localized skin or cervical carcinomas 12. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study 13. Untreated or uncontrolled active bacterial, fungal, or viral infection 14. Participation in other interventional clinical studies within 30 days prior to Day 1 15. 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 16. Women who are pregnant or breastfeeding 17. Known hypersensitivity to any component of the study drug
研究者
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