NCT03256838已完成4 期
A Long-Term, Open-Label, Prospective Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 9
- 主要终点
- Number of subjects with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
详细描述
This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Is ≧ 18 years of age on the day of signing informed consent or other age required by local regulation
- •Willing and able to provide written informed consent
- •ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician
- •Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment Visit
- •Women of child-bearing potential (WOCBP [defined as women ≤ 50 years of age with a history of amenorrhea for < 12 months prior to study entry]) who is willing to use an effective form of contraception during study participation
排除标准
- •Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:
- •i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or iron overload syndromes iv. Has active severe GI disorders
- •Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3 months prior to Enrollment Visit or serum calcium < 7 mg/dL at the Enrollment Visit
- •Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
- •Is currently pregnant or breastfeeding
- •Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment
研究组 & 干预措施
Ferric citrate
Experimental
Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
干预措施: Ferric Citrate (Drug)
结局指标
主要结局
Number of subjects with treatment-emergent adverse events (TEAEs)
时间窗: 13 months
Number of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
时间窗: 13 months
Percentage of subjects with treatment-emergent adverse events (TEAEs)
次要结局
- Serum Phosphorus(13 months)
研究者
研究点 (9)
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