Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Determine the Effect of Ferric Citrate on Time to a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality vs Placebo in Adults With Advanced CKD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 289
- 试验地点
- 15
- 主要终点
- Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
研究概览
简要总结
A 9-month randomized, double-blind, placebo-controlled study to compare the effect of fixed dose ferric citrate versus placebo in patients with advanced chronic kidney disease (eGFR ≤20 ml/min/1.73m2) on the composite endpoint of time to initiation of maintenance dialysis or all-cause mortality.
详细描述
This multicenter, randomized, double-blind, placebo-controlled clinical trial is being conducted to determine the effect of ferric citrate on the time to a composite endpoint of initiation of maintenance dialysis or all-cause mortality in patients with non-dialysis dependent, advanced CKD. Up to 400 subjects will be randomized in 1:1 ratio to receive either ferric citrate or matching placebo. All subjects will initiate dosing at 2 tablets per meal or snacks, up to 3 times per day (maximum of 6 tablets per day). The dose of ferric citrate/placebo will only be adjusted based on safety and/or tolerability. Given the double-blind design of this trial, investigators will be instructed to not prescribe commercial Auryxia to either study arm. Study visits during the treatment period are to be conducted as part of routine scheduled clinical encounters. Standard of care local laboratory results will be collected however no study specific laboratory tests other than a pregnancy test in women of child-bearing potential will be required.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 patients greater or equal to 18 years old.
- •Diagnosis of NDD advanced CKD, regardless of etiology. Advanced CKD is defined as at least one local laboratory determined estimated glomerular filtration rate (eGFR) ≤20 ml/min/1.73m2 (calculated per any commonly used method or equation for estimating eGFR) within 90 days of Day
- •Most recent transferrin saturation (TSAT) less than or equal to 45% within 45 days of Day
- •Most recent serum phosphate is greater or equal to 3.0 mg per dL within 45 days of Day
- •Most recent ferritin is less than or equal to 500 ng per mL within 45 days of Day
- •Women of child-bearing potential must have a negative serum or urine pregnancy test within 28 days prior to Day
- •Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.
排除标准
- •Patients who, in the opinion of the Investigator, have acute kidney injury rather than CKD.
- •Patients with planned/imminent maintenance dialysis, or that are anticipated to begin maintenance dialysis within 8 weeks from Screening, in the opinion of the Investigator.
- •A known allergy or intolerance to ferric citrate or any of its constituents.
- •Hypersensitivity reaction to previous oral iron therapy.
- •History of hemochromatosis or iron overload syndrome (e.g., hereditary sideroblastic anemia, thalassemia, polycythemia vera).
- •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 use of medical 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.
- •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 a clinically active infection requiring antibiotics at Randomization.
- •Unable to comply with study requirements or in the opinion of the Investigator, not clinically stable to participate in the study.
- •Use of an investigational medication or participation in an investigational study within 30 days prior to Day
- •Patients with a scheduled date for receipt of living donor kidney transplant
研究组 & 干预措施
Ferric citrate
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 GM Oral Tablet [AURYXIA] (Drug)
Placebo
Tablets, matching in color and size to ferric citrate.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Achieving a Composite Endpoint of Initiation of Maintenance Dialysis or All-cause Mortality
时间窗: 9 months
Number of participants achieving a composite endpoint of initiation of maintenance dialysis or all-cause mortality
次要结局
- Hospitalization Events Reported as a Serious Adverse Event (SAE) (Excluding Disease-related Hospitalization [e.g., Dialysis Access Placement, Dialysis Initiation, Kidney Transplant] and Elective Procedures)(9 months)
- Component of Primary - Initiation of Maintenance Dialysis(9 months)
- Component of Primary - All-Cause Mortality(9 months)