A Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Impact of Auryxia (Ferric Citrate) on Erythropoiesis-Stimulating Agent (ESA) Use, Intravenous (IV) Iron Use, Phosphate Control, and Anemia Control in Adult Participants on In-Center Hemodialysis or Home Dialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 13
- 主要终点
- Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
研究概览
简要总结
This study is being conducted to demonstrate the effect of Auryxia, when used as the primary phosphate lowering therapy, on the overall cumulative use of erythropoiesis-stimulating agent and intravenous iron as well as on the laboratory parameters indicative of phosphate and anemia management.
详细描述
Approximately 200 participants will be randomized 1:1 (stratified by modality and hemoglobin level) to receive either Auryxia or standard of care phosphate lowering therapy to determine the impact of Auryxia when used as the primary phosphate lowering therapy as compared to standard of care on the utilization of erythropoiesis-stimulating agent and intravenous iron in both in-center and home dialysis populations. This study will also seek to determine the impact of Auryxia, when used as the primary phosphate lowering therapy versus standard of care, on the biochemical assessments of serum phosphate and hemoglobin in both in-center and home dialysis populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Adult participants greater or equal to 18 years old.
- •Diagnosis of end-stage kidney disease and receiving maintenance dialysis (in-center, home hemodialysis or peritoneal dialysis) for greater or equal to 12 weeks prior to randomization.
- •Most recent transferrin saturation less than or equal to 50 percent
- •Most recent serum phosphate is greater or equal to 3.0 milligrams per deciliter
- •Receiving treatment for greater or equal to 8 weeks prior to screening with non-Auryxia phosphate lowering therapy. No requirement for stable dosing within this time frame.
- •Receiving treatment for greater or equal to 8 weeks prior to screening with erythropoiesis-stimulating agent (any dose, any type). No requirement for stable dosing within this time frame.
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
排除标准
- •A known allergy or intolerance to Auryxia or any of its constituents.
- •Hypersensitivity reaction to previous oral iron therapy.
- •History of hemochromatosis or other iron overload syndrome.
- •Active malignancy requiring current treatment except for non-melanoma skin cancer regardless of treatment.
- •Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal or recreational marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the Investigator).
- •Limited life expectancy (less than 6 months), (in the opinion of the Investigator).
- •Scheduled organ transplant and participants on the kidney transplant wait-list who are expected to receive a transplant within 6 months of screening. Being active on transplant list is not an exclusion. Previous kidney transplant is not an exclusion.
- •Unable to comply with study requirements or in the opinion of the Investigator not clinically stable to participate in the study.
- •Females who are known to be pregnant or are breast-feeding during Screening or are planning to become pregnant and breastfeeding during the study period.
- •Evidence of clinically active infection at the time of Screening.
- •Use of an investigational medication or participation in an investigational study within 30 days prior to Screening.
研究组 & 干预措施
Ferric citrate (commercially available, Auryxia)
Ferric citrate, (commercially available Auryxia), supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.
干预措施: Ferric Citrate 1 gram Oral Tablet (Drug)
Standard of care phosphate lowering therapy
Non-Auryxia phosphate-lowering therapy administered as standard of care.
干预措施: Standard of care phosphate-lowering therapy (Drug)
结局指标
主要结局
Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
时间窗: Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period)
Difference in change from baseline period (Month -3 to Day 1) to months 4 to 6 (efficacy evaluation period) in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups.
Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups.
时间窗: Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Difference in change from baseline period to efficacy evaluation period in mean dose of intravenous iron (milligrams per month) between Auryxia and standard of care treatment groups.
次要结局
- Difference in hemoglobin measurements(Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).)
- Difference in serum phosphate measurements(Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period))