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

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with end stage renal disease who are receiving dialysis

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

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Locations

United States, Arizona
Southwest Kidney Institute, PLC
Tempe, Arizona, United States, 85284
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States, 85012
University of Arizona Health Service Center
Tuscon, Arizona, United States, 85724
DSI Renal Inc.
Mesa, Arizona, United States, 85202

Tempe, Arizona, United States, 85284
United States, Arkansas
Clinical Research Connections
Jonesboro, Arkansas, United States, 72401
United States, California
South Valley Dialysis Center
Encino, California, United States, 91316
North Valley Nephrology
Yuba City, California, United States, 95991
VA Greater Los Angeles Health Care System, West LA
Los Angeles, California, United States, 90073
Apex Research of Riverside
Riverside, California, United States, 92505
United States, Colorado
Western Nephrology & Metabolic Bone Disease, PC
Thornton, Colorado, United States, 80260
United States, Florida
Pines Clinical Research
Pembroke Pines, Florida, United States, 33028
Discovery Medical Research Group
Ocala, Florida, United States, 34471
Shands University of Florida Outpatient Dialysis
Gainesville, Florida, United States, 32608
Clinical Research Center of Indian River Medical Center
Vero Beach, Florida, United States
United States, Georgia
Renal Physicians of Georgia
Macon, Georgia, United States, 31217
Kidney Care Associates, LLC
Augusta, Georgia, United States, 30901
United States, Illinois
Research by Design, LLC
Evergreen Park, Illinois, United States, 60805
Evanston Northwestern Hospital
Evanston, Illinois, United States, 60201
United States, Indiana
Nephrology Inc.
Mishawaka, Indiana, United States, 46545
United States, Louisiana
Renal Associates of Baton Rouge
Baton Rouge, Louisiana, United States, 70809
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Hypertension and Nephrology, Associates
Eatontown, New Jersey, United States, 07724
United States, New York
Winthrop Dialysis Center
Mineola, New York, United States, 11501
SUNY at Stony Brook NY
Stony Brook, New York, United States, 11794
United States, North Carolina
Wake Nephrology Associates
Raleigh, North Carolina, United States, 27609
Southeastern Nephrology Associates
Wilmington, North Carolina, United States, 28401
United States, Oregon
Northwest Renal Clinic
Portland, Oregon, United States, 97210
United States, South Carolina
Carolina Nephrology, PA
Greenville, South Carolina, United States, 29605
United States, Tennessee
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States, 37212
United States, Texas
University of Texas Health Science Center at San Antonio Medicine/Nephrology
San Antonio, Texas, United States, 78229
Rosa Verde Tower
San Antonio, Texas, United States, 78205
United States, Virginia
Alexandria Kidney
Alexandria, Virginia, United States, 22304
Clinical Research & Consulting Center, LLC
Fairfax, Virginia, United States, 22030
Germany
KfH Dialysezentrum/Berlin
Berlin, Germany, 12045
Dialysezentrum Barmbeck
Hamburg, Germany, 22297
KfH Nierenzentrum/Dulmen
Dulmen, Germany, 48249
KfH Nierenzentrum
Berlin, Germany, 10559
Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
Gottingen, Germany, 37075
KfH Nierenzentrum/Bad/Konig
Bad Konig, Germany, 64732
KfH-Nierenzentrum/Jena
Jena, Germany, 07751
KfH-Dialysezentrum/Rosenheim
Rosenheim, Germany, 83022
Puerto Rico
Jose Cangiano, MD
San Juan, Puerto Rico, 00918
United Kingdom
Churchill Hospital Oxford Kidney Unit
Oxford, United Kingdom, OX3 7LJ

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