Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period.
Placebo
VA Greater Los Angeles Health Care System
Los Angeles, California, United States
Barnett Research & Communications Medical Corporation
Torrance, California, United States
Western Nephrology & Metabolic Bone Disease, PC
Thornton, Colorado, United States
Serum phosphorus levels at 8 weeks.
Time frame: 8 weeks
PTH levels, calcium-phosphorus product.
Time frame: 8 weeks
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Outcomes Research International, Inc.
Hudson, Florida, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States
St. Louis University/Nephrology
St Louis, Missouri, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Northwest Renal Clinic
Portland, Oregon, United States
Nephrology Associates
Nashville, Tennessee, United States
Kidney Associates
Houston, Texas, United States