- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750295
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
December 11, 2020 updated by: Novartis Pharmaceuticals
An Open Label, Multiple Dose, Time-lagged, Switch Study to Evaluate the Safety, Tolerability and Activity of Escalating SBR759 Doses in Patients With Chronic Kidney Disease on Hemodialysis
The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Denver, Colorado, United States, 80230
- Novartis Investigator Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
- 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 been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
- 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.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
Experimental: 2
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
Experimental: 3
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
Experimental: 4
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
Experimental: 5
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
Experimental: 6
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
Experimental: 7
|
Four weeks of treatment with different doses of SBR759.
Patients maintain their prescribed dose of other phosphate binders during the run-in period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
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Secondary Outcome Measures
Outcome Measure |
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Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
September 9, 2008
First Submitted That Met QC Criteria
September 9, 2008
First Posted (Estimate)
September 10, 2008
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSBR759A2101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
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Clinical Trials on SBR759
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Novartis PharmaceuticalsCompletedChronic Kidney DiseaseTaiwan, Japan