An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate

Study Overview
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Brief Summary
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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.

Detailed Description
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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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

Official Title
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A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia

Conditions
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Chronic Kidney Failure

Intervention / Treatment
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* Drug: Fermagate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment Male or female subjects on active haemodialysis, aged 18 years or over Willing to abstain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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermagate<br> | Drug: Fermagate<br>* Film coated tablet 500mg<br>* Other names: Alpharen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of AEs and other safety parameters |  | 88 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of serum phosphate concentrations |  | 88 weeks |