LBCTR2022125202尚未招募2 期
A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment, With or Without Dialysis - PHYOX7
Dicerna Pharmaceuticals0 个研究点目标入组 30 人开始时间: 2024年2月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 0 至 99（—）
- 性别
- All
入选标准
- •Key inclusion criteria include:
- •Genetically confirmed PH1 or PH2
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min normalized to 1.73 m2 body surface area (BSA)
- •Mean of 2 Pox values > 20 µmol/L during Screening
- •For participants receiving hemodialysis or peritoneal dialysis, total duration of hemodialysis or peritoneal dialysis must be less than or equal to 18 months and stable dialysis regimen for at least 2 weeks prior to Screening
- •Willing to adhere to a low oxalate diet and avoid high doses of vitamin C
排除标准
- •Key exclusion criteria include:
- •Hepatic transplantation, prior to or planned in the 6 months from Day 1. Renal transplantation planned in the 6 months from Day 1. Prior renal transplantation is allowed.
- •Documented evidence of clinical manifestations of systemic oxalosis
研究者
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