A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
NCT ID: NCT00750295
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
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2007-02-28
2008-01-31
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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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
2
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
3
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
4
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
5
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
6
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
7
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Interventions
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SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
SBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Eligibility Criteria
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Inclusion Criteria
* A controlled serum phosphorus.
* Constant dose of concomitant medications.
* Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.
Exclusion Criteria
* Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
* Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.
18 Years
85 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: PRINCIPAL_INVESTIGATOR
Novartis Investigator Site
Locations
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Novartis Investigator Site
Denver, Colorado, United States
Countries
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Related Links
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Results for CSBR759A2101 from the Novartis Clinical Trials website
Other Identifiers
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CSBR759A2101
Identifier Type: -
Identifier Source: org_study_id