Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
SBR759
A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
2 other identifiers
interventional
321
13 countries
66
Brief Summary
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedDecember 19, 2020
November 1, 2016
2.1 years
June 23, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
Time Frame: 12 weeks + 12 months
Secondary Outcomes (1)
Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months
Time Frame: 12 weeks / 12 months
Study Arms (4)
1
EXPERIMENTAL1g tid
2
ACTIVE COMPARATORSevelamer HCl
3
EXPERIMENTALSBR759 1.5 g tid
4
ACTIVE COMPARATORSevelamer HCl
Interventions
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
Eligibility Criteria
You may qualify if:
- Men or women of at least 18 years old.
- 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.
You may not qualify if:
- Peritoneal dialysis.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Novartis
Chula Vista, California, 91910, United States
Novartis
La Mesa, California, 91942, United States
Novartis
Whittier, California, 90602, United States
Novartis
Denver, Colorado, 80262, United States
Novartis
North Chicago, Illinois, 60064, United States
Novartis
Peoria, Illinois, 61602, United States
Novartis
Mishawaka, Indiana, 46545, United States
Novartis
Baltimore, Maryland, 21287, United States
Novartis
Fall River, Massachusetts, 02720, United States
Novartis
Springfield, Massachusetts, 01104, United States
Novartis Investigative Site
Omaha, Nebraska, 68144, United States
Novartis
New York, New York, 10032, United States
Novartis
Winston-Salem, North Carolina, 27157-1082, United States
Novarits
Fargo, North Dakota, 58103, United States
Novartis
Portland, Oregon, 97210, United States
Novartis
Pittsburgh, Pennsylvania, 15224, United States
Novartis Investigative Site
Houston, Texas, 77024, United States
Novartis
San Antonio, Texas, 78207, United States
Novartis
Fairfax, Virginia, 22031, United States
Novartis
Adelaide, South Australia, Australia
Novartis
Fitzroy, Victoria, Australia
Novartis
Parkville, Victoria, 3052, Australia
Novartis
Melbourne, 3065, Australia
Novartis
South Brisbane, Australia
Novartis
Woolloongabba, 4102, Australia
Novartis Investigative Site
Antwerp, Belgium
Novartis
Bruges, 8000, Belgium
Novartis
Brussels, 1000, Belgium
Novartis
Liège, 4000, Belgium
Novartis Investigative Site
Saint Niklaas, Belgium
Novartis Investigative Site
Edmonton, Canada
Novartis Investigative Site
London, Canada
Novartis Investigative Site
Oshawa, Canada
Novartis Investigative Site
Québec, Canada
Novartis
Helsinki, 00100, Finland
Novartis
Oulu, 90100, Finland
Novartis
Tampere, 33100, Finland
Novartis
Turku, 20100, Finland
Novartis
Amiens, 80054, France
Novartis
Fleury-Mérogis, France
Novartis
Lyon, 69446, France
Novartis
Reims, 51685, France
Novartis
Salouël, 80480, France
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Coburg, Germany
Novartis Investigative Site
Lecco, Italy
Novartis Investigative Site
Lodi, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Modena, Italy
Novartis Investigative Site
Pavia, Italy
Novartis
Bergen, 5011, Norway
Novartis
Kristiansand, 1001, Norway
Novartis
Oslo, 0027, Norway
Novartis
Tønsberg, Norway
Novartis
San Juan, 00927, Puerto Rico
Novartis Investigative Site
Jönköping, Sweden
Novartis Investigative Site
Karlstad, Sweden
Novartis Investigative Site
Skövde, Sweden
Novartis Investigative Site
Stockholm, Sweden
Novartis
Aarau, 5000, Switzerland
Novartis
Lausanne, 1011, Switzerland
Novartis
Zurich, 8091, Switzerland
Novartis
Hull, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Novartis Investigative Site
Portsmouth, United Kingdom
Novartis
Salford, United Kingdom
Related Publications (1)
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.
PMID: 21854503RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 25, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2010
Last Updated
December 19, 2020
Record last verified: 2016-11