A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 11
- 主要终点
- Adverse Event (AE) Query
研究概览
简要总结
A Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome
详细描述
ADX-629-MCD-001 is a multi-center, two-part, Phase 2 clinical trial designed to evaluate the safety and efficacy of ADX-629 in Subjects with frequently relapsing and steroid-dependent nephrotic syndrome. Study drug will be administered orally every 12 hours (twice daily) to eligible subjects for 90 days. The study will enroll approximately 35 children and adults with nephrotic syndrome who have had a nephrotic relapse in the 6 months prior to screening.
The clinical trial is divided into 2 parts: Part 1 (open-label) and Part 2 (double-blinded, randomized).
Part 1: Approximately 5 eligible subjects will receive open-label ADX-629 (250 mg) twice daily for 90 days.
Part 2: Approximately 30 eligible subjects will be randomized in a 2:1 ratio to receive either ADX-629 (250 mg) or matching placebo twice daily for 90 days.
Patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age
- •History of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia
- •Recent nephrotic relapse in the 6 months prior to screening
- •Estimated glomerular filtration rate (eGFR) of ≥45 during screening
- •Not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable
排除标准
- •Subjects with collapsing FSGS focal segmental glomerulosclerosis (FSGS)
- •Known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria)
- •History of kidney transplantation or other solid organ transplantation
- •History of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the Investigator, could compromise subject safety or affect the conduct of the trial
研究组 & 干预措施
ADX-629
干预措施: ADX-629 (Drug)
结局指标
主要结局
Adverse Event (AE) Query
时间窗: From Day 1 to Day 90
Incidence and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
次要结局
- Relapse Frequency(From Day 1 to Day 90)