Head to Head Study Against Sevelamer Hydrochloride - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00441545

Purpose

To compare the efficacy of Fosrenol and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Condition	Intervention	Phase
Chronic Kidney Disease, Stage 5	Drug: Lanthanum Carbonate Drug: Sevelamer hydrochloride	Phase III

MedlinePlus related topics: Kidney Failure

Drug Information available for: Sevelamer Sevelamer carbonate Sevelamer hydrochloride Lanthanum Carbonate

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Multicenter, Open-Label, Randomized, Cross-Over Study to Compare the Efficacy and Safety of Fosrenol® and Sevelamer Hydrochloride in Patients Receiving Hemodialysis for End Stage Renal Disease

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Change from baseline in serum phosphorus levels at the end of each treatment period. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum phosphorus, calcium and PTH at each visit. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	February 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Lanthanum Carbonate The starting dose is a total daily dose of 2250mg of lanthanum carbonate to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
2: Active Comparator	Drug: 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.

Detailed Description:

To compare the efficacy of Fosrenol and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Subjects with significant gastrointestinal disorders
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441545

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Stuart Sprague, D.O.

Evanston Northwestern Hospital

More Information

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD405-319
Study First Received:	February 27, 2007
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00441545
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sevelamer
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009