Fosrenol and Phosphorus Balance - Lanthanum Carbonate
Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
Participant gender:
Summary
Positive phosphorus balance and hyperphosphatemia (increased serum phosphorus levels) are
very common complications of people with advanced chronic kidney disease (i.e., stage 5 CKD),
including chronic dialysis patients, and are associated with severe morbidity and increased
mortality. Despite attempts to control serum phosphorus with dietary phosphorus restriction
and the use of medicines that bind phosphorus in the gastrointestinal tract so that the
phosphorus cannot be absorbed into the body( also called phosphate binders), chronic dialysis
patients frequently remain hyperphosphatemic, particularly at the time when they commence
each of their regular dialysis treatments.
Fosrenol (lanthanum carbonate, manufactured by Shire Pharmaceuticals) is a gastrointestinal
phosphate binder that appears to have the advantages of being safe, well tolerated and
effective at binding phosphate. There are limited data on the magnitude of binding of
phosphorus by Fosrenol in the human gastrointestinal tract of patients with chronic kidney
disease.
The specific aims for this proposal are as follows:
1. To quantify, under precisely controlled metabolic balance conditions, the increase in
fecal excretion of dietary phosphorus that occurs when patients undergoing chronic
peritoneal dialysis (CPD) ingest Fosrenol (lanthanum carbonate).
2. To examine a dose response relationship between Fosrenol treatment and fecal phosphorus
excretion. The investigators will examine in CPD patients ingesting a constant
phosphorus intake, how much additional phosphorus is excreted in the feces at three
different dose levels of Fosrenol, 1.5, 3.0, and 4.5 g/day.
3. To examine how increased fecal phosphorus losses and more negative phosphorus balance
caused by Fosrenol intake affects serum phosphorus and such hormonal regulators of
phosphorus metabolism as serum parathyroid hormone (PTH), fibroblast growth factor-23,
25-hydroxycholecalciferol (25(OH)D3), 1,25-dihydroxycholecalciferol (1,25(OH)2D3) and
fetuin-A.
4. To assess whether there is any effect of Fosrenol and increased intestinal phosphate
binding on protein-nitrogen balance.
Phase:
N/A
Details
Lead Sponsor:
Los Angeles Biomedical Research Institute Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center