Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
NCT ID: NCT01069692
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
PHASE3
115 participants
INTERVENTIONAL
2010-02-28
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
DOUBLE
Study Groups
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Arm 1
Placebo
SBR759A
Placebo Comparator 0g daily
Arm 3
SBR759A
SBR759A 6g daily
Arm 2
SBR759A
SBR759A 3g daily
arm 4
SBR759A
SBR759A
9g daily
arm 5
SBR759A
12g daily
Interventions
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SBR759A
SBR759A 6g daily
SBR759A
Placebo Comparator 0g daily
SBR759A
SBR759A 3g daily
SBR759A
9g daily
SBR759A
12g daily
Eligibility Criteria
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Inclusion Criteria
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening
Exclusion Criteria
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin \> 1000 ng/mL
7. Transferrin saturation \> 60%
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Jette, , Belgium
Novartis Investigative Site
Liège, , Belgium
Novartis Investigative Site
Roeselare, , Belgium
Novartis Investigative Site
Brescia, , Italy
Novartis Investigative Site
Lecco, , Italy
Novartis Investigator Site
Lucca, , Italy
Novartis Investigative Site
Napoli, , Italy
Novartis Investigative Site
Pavia, , Italy
Novartis Investigative Site
Siena, , Italy
Countries
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References
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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.
Related Links
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Results for CSBR759A2304 from the Novartis Clinical Trials website
Other Identifiers
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2008-006097-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSBR759A2304
Identifier Type: -
Identifier Source: org_study_id