Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
84 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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