A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 36
- 主要终点
- Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
研究概览
简要总结
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").
详细描述
a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline
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
- •Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening
- •Age ≥18 years
- •CKD with Estimated Glomerular Filtration Rate (eGFR) <60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR <15 mL/min)
- •Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)
- •Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening
- •Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening
- •Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening
- •Must consume a minimum of 2 meals per day
- •Willing and able to give written informed consent
排除标准
- •Serum phosphate <3.5 mg/dL at Screening
- •Liver enzymes (ALT/AST) >X3 times upper limit of normal at Screening
- •Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening
- •Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening
- •Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening
- •IV iron administered within 4 weeks prior to Screening
- •Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening
- •Blood transfusion within 4 weeks prior to Screening
- •Receipt of any investigational drug within 4 weeks prior to Screening
- •Cause of anemia other than iron deficiency or chronic kidney disease
- •Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)
- •History of hemochromatosis
- •Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)
- •Subjects with known allergic reaction to previous oral iron therapy
- •Previous intolerance to oral ferric citrate
- •Psychiatric disorder that interferes with the subject's ability to comply with the study protocol
- •Planned surgery or hospitalization (anticipated to last >72 hours) during the randomized period of the trial other than dialysis access related surgery.
- •Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
- •Inability to cooperate with study personnel
研究组 & 干预措施
KRX-0502 (ferric citrate)
1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron
干预措施: ferric citrate (Drug)
Placebo
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period
时间窗: Week 16
Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.
次要结局
- Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline(Baseline and week 16)
- Mean Change in Ferritin at the End of 16 Weeks Minus Baseline(Baseline and week 16)
- Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline(Baseline and week 16)
- Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline(Baseline and week 16)
- Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)(Week 16)