Efficacy and Safety of Lanthanum Carbonate in Reducing Serum Phosphorus Levels in Subjects With Stage 3 and 4 Chronic Kidney Disease
NCT ID: NCT00234702
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2006-01-11
2007-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
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.
2
Placebo
Placebo
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Screening estimated GFR of 15-59 mL/1.73 m2
* Serum phosphorus \>= 4.7 mg/d following washout
Exclusion Criteria
* Rapidly progressing glomerulonephritis
* Cirrhosis or other clinically significant liver diseases
* Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Countries
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References
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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.
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Related Links
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FDA Recall Information
Other Identifiers
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SPD405-206
Identifier Type: -
Identifier Source: org_study_id
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