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.
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took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Film coated tablet 500mg
1614 West 42nd Street
Pine Bluff, Arkansas, United States
US Renal Care
Stuttgart, Arkansas, United States
Assessment of AEs and other safety parameters
Time frame: 88 weeks
Assessment of serum phosphate concentrations
Time frame: 88 weeks
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