Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
182 participants
INTERVENTIONAL
2007-01-05
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Fosrenol (Lanthanum carbonate)
Fosrenol (Lanthanum Carbonate)
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
2
Sevelamer hydrochloride
Sevelamer hydrochloride
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
Interventions
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Fosrenol (Lanthanum Carbonate)
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
Sevelamer hydrochloride
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects who are pregnant or nursing
* Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
* Subjects who are HIV positive
* Subjects with clinical significant liver disease
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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DSI Renal Inc.
Mesa, Arizona, United States
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States
Southwest Kidney Institute, PLC
Tempe, Arizona, United States
Tempe, Arizona, United States
University of Arizona Health Service Center
Tucson, Arizona, United States
Clinical Research Connections
Jonesboro, Arkansas, United States
South Valley Dialysis Center
Encino, California, United States
VA Greater Los Angeles Health Care System, West LA
Los Angeles, California, United States
Apex Research of Riverside
Riverside, California, United States
North Valley Nephrology
Yuba City, California, United States
Western Nephrology & Metabolic Bone Disease, PC
Thornton, Colorado, United States
Shands University of Florida Outpatient Dialysis
Gainesville, Florida, United States
Discovery Medical Research Group
Ocala, Florida, United States
Pines Clinical Research
Pembroke Pines, Florida, United States
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, United States
Kidney Care Associates, LLC
Augusta, Georgia, United States
Renal Physicians of Georgia
Macon, Georgia, United States
Evanston Northwestern Hospital
Evanston, Illinois, United States
Research by Design, LLC
Evergreen Park, Illinois, United States
Nephrology Inc.
Mishawaka, Indiana, United States
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Hypertension and Nephrology, Associates
Eatontown, New Jersey, United States
Winthrop Dialysis Center
Mineola, New York, United States
SUNY at Stony Brook NY
Stony Brook, New York, United States
Wake Nephrology Associates
Raleigh, North Carolina, United States
Southeastern Nephrology Associates
Wilmington, North Carolina, United States
Northwest Renal Clinic
Portland, Oregon, United States
Carolina Nephrology, PA
Greenville, South Carolina, United States
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States
Rosa Verde Tower
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio Medicine/Nephrology
San Antonio, Texas, United States
Alexandria Kidney
Alexandria, Virginia, United States
Clinical Research & Consulting Center, LLC
Fairfax, Virginia, United States
KfH Nierenzentrum/Bad/Konig
Bad König, , Germany
KfH Nierenzentrum
Berlin, , Germany
KfH Dialysezentrum/Berlin
Berlin, , Germany
KfH Nierenzentrum/Dulmen
Dülmen, , Germany
Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
Göttingen, , Germany
Dialysezentrum Barmbeck
Hamburg, , Germany
KfH-Nierenzentrum/Jena
Jena, , Germany
KfH-Dialysezentrum/Rosenheim
Rosenheim, , Germany
Jose Cangiano, MD
San Juan, , Puerto Rico
Churchill Hospital Oxford Kidney Unit
Oxford, , United Kingdom
Countries
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References
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Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252.
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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2006-004959-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SPD405-319
Identifier Type: -
Identifier Source: org_study_id
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