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

Kidney Diseases Clinical Trial

Official title:

A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234702
• Other study ID #: SPD405-206
• Status: Completed
• Phase: Phase 2
• Start date: January 11, 2006
• Est. completion date: June 1, 2007

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 1, 2007
• Est. primary completion date: June 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lanthanum carbonate
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
Placebo

Locations

Country	Name	City	State
United States	Twin Cities Clinical Research	Brooklyn Center	Minnesota
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Kidney Associates	Houston	Texas
United States	Outcomes Research International, Inc.	Hudson	Florida
United States	VA Greater Los Angeles Health Care System	Los Angeles	California
United States	Nephrology Associates	Nashville	Tennessee
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	Barnett Research & Communications Medical Corporation	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. doi: 10.2215/CJN.02830608. Epub 2008 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum phosphorus levels at 8 weeks.		8 weeks
Secondary	PTH levels, calcium-phosphorus product.		8 weeks

External Links

•   FDA Recall Information
•   FDA-approved Label