To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks
Matching placebo chewable tablets administered 3 times a day for 12 weeks
Dr Pablo Urena Torres
Saint-Ouen, Paris, France
Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF)
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
Time frame: 12 Weeks
Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF)
Time frame: 12 Weeks
Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Serum Phosphate Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF)
Time frame: 12 weeks
Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF)
Time frame: 12 weeks
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