Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Kidney Diseases

In brief

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.

Key facts

Study ID

NCT00234702

Run by

Shire

People needed

84

Starts

2006-01-11

Expected to finish

2007-06-01

Last updated by the study team

2021-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Under a physician's care for CKD for > 2 months and are not expected to begin dialysis for 4 months
• Screening estimated GFR of 15-59 mL/1.73 m2
• Serum phosphorus >= 4.7 mg/d following washout

You may not qualify if…

• Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium
• Rapidly progressing glomerulonephritis
• Cirrhosis or other clinically significant liver diseases
• Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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