Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Phosphorus Levels
研究概览
简要总结
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
详细描述
PROTOCOL SUMMARY
Title: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Short Title: FeCitrate
Protocol Number: KP FeCitrate
Study Phase: 4
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
- •Mean serum phosphorus 4.0-<8.0 mg/dl for 6 months prior to enrollment
- •No allergy to iron
- •Mean corrected serum calcium > 8.0 mg/dl for 6 months prior to enrollment
- •Mean PTH < 1000 pg/ml for 6 months prior to enrollment
- •Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment
排除标准
- •History of gastrointestinal bleeding within past 6 months
- •History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
- •Acute kidney injury equal to or less than 3 months before the initial screening date
- •Active malignancy
- •Functioning renal transplant
- •Patients with iron overload syndrome (e.g., Hemochromatosis)
- •History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease
- •Active or past history of calciphylaxis
研究组 & 干预措施
Ferric Citrate
Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.
干预措施: Ferric Citrate (Drug)
结局指标
主要结局
Phosphorus Levels
时间窗: 6 months
Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use
次要结局
- Erythropoiesis Stimulating Agents (ESA) Dose(6 months)
- Median Pill Count(6 months)
- Intravenous (IV) Iron(6 months)