Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
NCT ID: NCT00704483
Last Updated: 2020-12-19
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
321 participants
INTERVENTIONAL
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
1g tid
SBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
2
Sevelamer HCl
Sevelamer HCl
0.8 g tid
3
SBR759 1.5 g tid
SBR759
1.5 g tid
4
Sevelamer HCl
Sevelamer HCl
1.6 g tid
Interventions
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SBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
Sevelamer HCl
0.8 g tid
SBR759
1.5 g tid
Sevelamer HCl
1.6 g tid
Eligibility Criteria
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Inclusion Criteria
* Stable maintenance of renal replacement therapy 3 times per week.
* Controlled Serum phosphate if under phosphate-binder therapy.
* Serum phosphate level ≥ 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation.
Exclusion Criteria
* Parathyroidectomy or transplant scheduled during the study.
* Uncontrolled hyperparathyroidism
* History of hemochromatosis or ferritin \> 1000 µg/L.
* Clinically significant GI disorder
* Unstable medical condition other than Chronic Kidney Disease.
* Treated with oral iron.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
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Novartis
Chula Vista, California, United States
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La Mesa, California, United States
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Whittier, California, United States
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Denver, Colorado, United States
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North Chicago, Illinois, United States
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Peoria, Illinois, United States
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Mishawaka, Indiana, United States
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Baltimore, Maryland, United States
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Fall River, Massachusetts, United States
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Springfield, Massachusetts, United States
Novartis Investigative Site
Omaha, Nebraska, United States
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New York, New York, United States
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Winston-Salem, North Carolina, United States
Novarits
Fargo, North Dakota, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Fairfax, Virginia, United States
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Adelaide, South Australia, Australia
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Fitzroy, Victoria, Australia
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Parkville, Victoria, Australia
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Melbourne, , Australia
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South Brisbane, , Australia
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Woolloongabba, , Australia
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Antwerp, , Belgium
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Bruges, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Saint Niklaas, , Belgium
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Edmonton, , Canada
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London, , Canada
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Oshawa, , Canada
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Québec, , Canada
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Helsinki, , Finland
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Oulu, , Finland
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Tampere, , Finland
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Turku, , Finland
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Amiens, , France
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Fleury-Mérogis, , France
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Lyon, , France
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Reims, , France
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Salouël, , France
Novartis Investigative Site
Berlin, , Germany
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Coburg, , Germany
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Lecco, , Italy
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Lodi, , Italy
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Milan, , Italy
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Modena, , Italy
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Pavia, , Italy
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Bergen, , Norway
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Kristiansand, , Norway
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Oslo, , Norway
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Tønsberg, , Norway
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San Juan, , Puerto Rico
Novartis Investigative Site
Jönköping, , Sweden
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Karlstad, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
Novartis
Aarau, , Switzerland
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Lausanne, , Switzerland
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Zurich, , Switzerland
Novartis
Hull, , United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Novartis Investigative Site
Portsmouth, , United Kingdom
Novartis
Salford, , United Kingdom
Countries
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References
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Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.
Related Links
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Results for CSBR759A2201 from the Novartis Clinical Trials Website
Other Identifiers
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EUDRACT No.: 2006-001787-23
Identifier Type: -
Identifier Source: secondary_id
CSBR759A2201
Identifier Type: -
Identifier Source: org_study_id