A Phase 2 Study of KRX-0502 (Ferric Citrate) in Managing Serum Phosphorus and Iron Deficiency in Anemic Subjects With Stage III to V Chronic Kidney Disease Not on Dialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 149
- 主要终点
- Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
研究概览
简要总结
The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic chronic kidney disease (CKD) stage 3-5 subjects not on dialysis. Total length of treatment is approximately 12 weeks.
详细描述
This is a randomized, double-blind, placebo-controlled, three-period, multi-center clinical trial. Following a Screening and Qualification Period and a two-week Washout Period (for those subjects entering the study on a phosphate binder), eligible subjects will be randomized in a 1:1 ratio to receive either KRX-0502 (ferric citrate) or placebo for up to approximately 12 weeks. The purpose of this study is to determine if KRX-0502 (ferric citrate) is a safe and effective treatment for the management of serum phosphorus levels and iron deficiency in anemic CKD subjects not on dialysis.
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
- Double (Participant, Investigator)
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
- •Stage III to V Chronic Kidney Disease
- •Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
- •Ferritin 300 ng/mL or less
- •Transferrin Saturation (TSAT) 30% or less
- •Hemoglobin >9.0 and <12.0 g/dL
- •Must consume a minimum of 2 meals per day
排除标准
- •Parathyroidectomy within 24 weeks of study
- •gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
- •Requirement for dialysis or kidney injury within 8 weeks of study
- •Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
- •Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
- •Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
- •History of hemochromatosis
- •Allergy to iron products
- •History of malignancy in last 5 years
研究组 & 干预措施
Placebo
Placebo will be taken with or within one hour of meals or snacks. The starting dose of placebo is 3 tablets per day and titrated by the subject's serum phosphorus results at each treatment visit.
干预措施: Placebo (Drug)
Ferric Citrate
Ferric citrate will be taken with or within one hour of meals or snacks. The starting dose of ferric citrate is 3 tablets/day and titrated by the subject's serum phosphorus results at each treatment visit.
干预措施: Ferric Citrate (Drug)
结局指标
主要结局
Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment
时间窗: 12 Weeks
The difference in TSAT between the value at the end of treatment (week 12) minus the baseline measurement.
Change in Serum Phosphorus Levels From Baseline to End of Treatment
时间窗: 12 Weeks
The difference in serum phosphorus between the value at the end of treatment (week 12) minus the baseline measurement.
次要结局
- Change in Ferritin Levels From Baseline to End of Treatment(12 Weeks)
- Change in Hemoglobin Levels From Baseline to End of Treatment(12 Weeks)