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

Phase 2

Completed

• Conditions: Kidney Diseases
• Interventions: Drug: Lanthanum carbonate; Drug: Placebo

• Registration Number: NCT00234702
• Lead Sponsor: Shire

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-10-05
• Study First Submitted QC: 2005-10-05
• Study First Posted: 2005-10-07
• Study Start: 2006-01-11
• Primary Completion: 2007-06-01
• Study Completion: 2007-06-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-04
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lanthanum carbonate	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Serum phosphorus levels at 8 weeks.	8 weeks

Secondary Outcome Measures

Name	Time	Method
PTH levels, calcium-phosphorus product.	8 weeks

Trial Locations

Locations (10)

VA Greater Los Angeles Health Care System; 🇺🇸 Los Angeles, California, United States

Northwest Renal Clinic; 🇺🇸 Portland, Oregon, United States

St. Louis University/Nephrology; 🇺🇸 Saint Louis, Missouri, United States

Western Nephrology & Metabolic Bone Disease, PC; 🇺🇸 Thornton, Colorado, United States

Outcomes Research International, Inc.; 🇺🇸 Hudson, Florida, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Barnett Research & Communications Medical Corporation; 🇺🇸 Torrance, California, United States

Nephrology Associates; 🇺🇸 Nashville, Tennessee, United States

Kidney Associates; 🇺🇸 Houston, Texas, United States

Twin Cities Clinical Research; 🇺🇸 Brooklyn Center, Minnesota, United States