Head to Head Study Against Sevelamer Hydrochloride - Full Text View

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

Purpose

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Change From Baseline in Serum Phosphorus Levels at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in Serum Calcium Levels at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	182
Study Start Date:	February 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fosrenol (Lanthanum carbonate)	Drug: 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: Active Comparator Sevelamer hydrochloride	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 (Lanthanum carbonate) 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

Additional Information:

FDA recall information This link exits the ClinicalTrials.gov site

FDA Medical Products Safety Alerts This link exits the ClinicalTrials.gov site

FDA-approved label This link exits the ClinicalTrials.gov site

Synopsis of study results This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	SPD405-319
Study First Received:	February 27, 2007
Results First Received:	June 29, 2009
Last Updated:	October 1, 2009
ClinicalTrials.gov Identifier:	NCT00441545 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sevelamer
Renal Insufficiency
Molecular Mechanisms of Pharmacological Action
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Chelating Agents
Kidney Diseases
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on November 27, 2009