A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 15
- 主要终点
- Assessment of AEs and other safety parameters
研究概览
简要总结
Fermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.
The purpose of this study it to look at the safety of fermagate over longer periods of time.
详细描述
High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease).
This study is an open-label, multi-centre, single-group, 24-week study of fermagatebonate. Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment
- •Male or female subjects on active haemodialysis, aged 18 years or over
- •Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication;
- •Willing to avoid any intentional changes in diet such as fasting, dieting or overeating;
- •Willing to maintain their usual type and dose of Vitamin D supplementation.
排除标准
- •Participation in any other clinical trial using an investigational product or device within the previous 4 months;
- •A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
- •Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn;
- •Clinically significant laboratory findings (for this subject population) in the opinion of the investigator.
- •Any malignancy with the exception of basal cell carcinoma;
- •A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;
- •A significant illness in the 4 weeks before screening;
- •Taking medication for seizures;
- •A history of haemochromatosis;
- •A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);
- •A history of dysphagia or swallowing disorders;
- •Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they abstain from sexual intercourse or are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device;
- •Current haemoglobin concentration of < 10.00 g/dL;
- •Allergy to the IMP or its constituents.
研究组 & 干预措施
Fermagate
干预措施: Fermagate (Drug)
结局指标
主要结局
Assessment of AEs and other safety parameters
时间窗: 88 weeks
次要结局
- Assessment of serum phosphate concentrations(88 weeks)