The main aim of this research study is to see if giving Fosrenol®, a chewable tablet, to patients on haemodialysis works as well as other treatments currently used to lower blood phosphorus levels.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
2250mg/day starting dose of lanthanum carbonate administered orally, in divided doses, with meals (500mg 750mg and 1000mg strengths)for 2 weeks; dose titration will occur based on serum phosphorus results not to exceed 3000mg/day.
Landeskrankenhaus Feldkirch, Abteilung fur Nephrologie und dialyse
Feldkirch Tisis, Austria
Krankenhaus Elisabethinen/Dialysestation
Linz, Austria
Ziekenhuis Zuid Oost Limburg
Genk, Belgium
Percentage of subjects achieving serum phosphorus levels of less than or equal to 1.78 mmol/L (5.5 mg/dL) following treatment with Fosrenol at Week 12 compared to treatment with their previous phosphate binder therapy
Time frame: 12 weeks
The maintenance of mean serum phosphorus levels following treatment with 2250 mg/day of Fosrenol
Time frame: at Week 2 compared to baseline
Biochemical and haematological parameters
Time frame: measured throughout the study
Assess safety & tolerability
Time frame: Throughout the study
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Frederica Sygehus
Fredericia, Denmark
Holbaek Sykehus
Holbæk, Denmark
Sygehus Viborg
Viborg, Denmark
Dialysezentrum Barmbek
Hamburg, Germany
Dialysezentrum Heilbronn
Heilbronn, Germany
Dialyse Leipzig
Leipzig, Germany
Nephrologisches Zentrum Emsland
Lingen, Germany
...and 4 more locations