A Phase 3 Study of PBF-1681 Comprising a 16-week, Placebo-controlled, Double-blind Randomized Period and an 8-week, Open-label Extension Period for the Treatment of Iron Deficiency Anemia in Patients With Non-Dialysis Dependent CKD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 12
- 主要终点
- Hemoglobin (Hgb)
研究概览
简要总结
To assess the safety and effectiveness of PBF-1681 for the treatment of Iron Deficiency Anemia in patients with Non-Dialysis Dependent Chronic Kidney Disease.
详细描述
This is a Phase 3, 24-week, multicenter study in Taiwan, comprising a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label extension period, where all subjects receive PBF-1681 (ferric citrate) ("Extension Period"). The study will consist of 10 visits over a period of 24 weeks. There will be a screening period of up to 14 days. Approximately 200 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either PBF-1681 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 or women ≥18 years of age at screening.
- •CKD with eGFR <60 mL/min at screening using the 4-variable Modification of Diet in Renal Disease equation, where up to 20% of subjects with eGFR <15 mL/min are allowed.
- •Hgb ≥9.0 g/dL and ≤11.5 g/dL at screening.
- •Serum ferritin <300 ng/mL and TSAT <30% at screening.
- •Serum iPTH ≤600 pg/mL at screening.
- •Must consume minimally 2 meals per day.
- •Willing to give written informed consent.
- •Women may be enrolled if they are:
- •Documented to be surgically sterile or postmenopausal (amenorrhea >1 year and follicle-stimulating hormone ≥30 mU/mL), or
- •Practicing true abstinence for at least 28 days prior to study drug administration until 30 days after study drug administration and having a negative serum pregnancy test at screening, or
- •Using 2 forms of highly effective contraception, out of which 1 should be a physical barrier (condom or diaphragm), and another method such as adequate hormonal method (eg, contraceptive implants, injectables, oral contraceptives) or non-hormonal methods (eg, intrauterine device, spermicidals) from screening or at least 2 weeks prior to study drug administration (whichever is earlier) until 30 days after the study drug administration and having a negative serum pregnancy test at screening.
排除标准
- •Cause of anemia other than iron deficiency.
- •Serum phosphate <3.0 mg/dL at screening.
- •IV iron administered within 4 weeks of the start of screening.
- •ESA administered within 4 weeks of the start of screening.
- •Blood transfusion within 4 weeks of the start of screening.
- •Liver enzymes (alanine aminotransferase [ALT]/aspartate aminotransferase [AST]) >3 times upper limit of normal (ULN) at screening.
- •Symptomatic GI bleeding or symptomatic inflammatory bowel disease within 12 weeks of the start of screening.
- •Concurrent GI diseases assessed by Investigators to be inappropriate for the study, eg, acute peptic ulcer, chronic ulcerative colitis, and regional enteritis.
- •Active infection requiring systemic antimicrobial treatment such as antibiotics, antiviral, or antifungals at screening.
- •Concomitant or prior malignancy, except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy.
- •Subjects with known allergic reaction to previous oral iron therapy.
- •Subjects who were intolerant to oral iron therapy.
- •History of hemochromatosis.
- •Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of the start of screening.
- •Planned surgery or hospitalization (anticipated to last >72 hours) during the Randomized Period of the study other than dialysis access-related surgery.
- •Any other medical condition that, in the Investigators' opinion, may disturb subject's completion or optimal participation of the study, act as a significant confounding variable, or carry significant risks to a subject.
研究组 & 干预措施
PBF-1681 (ferric citrate)
PBF-1681 (ferric citrate) will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals.
干预措施: Ferric citrate (Drug)
Placebo
Matching placebo will be dosed two times a day with the 2 largest meals (preferred) or three times a day with meals.
干预措施: Placebo (Drug)
结局指标
主要结局
Hemoglobin (Hgb)
时间窗: 16 weeks
The mean change from baseline to the end of the Randomized Period in Hgb.
次要结局
- Proportion of Subjects with ≥1.0 g/dL Hgb Increase at any time point(16 weeks)
- Transferring saturation (TSAT)(16 weeks)
- Ferritin(16 weeks)
- Serum Phosphate(16 weeks)
- Sustained increase in Hgb of ≥0.75 g/dL(16 weeks)