Back to resultsA Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SBR759
SBR759
SBR759
SBR759
SBR759
SBR759
SBR759
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease,, hemodialysis,, serum phosphorus,, phosphate binders
Eligibility Criteria
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.
Sites / Locations
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
5
6
7
Arm Description
Outcomes
Primary Outcome Measures
In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
Secondary Outcome Measures
Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
Full Information
NCT ID
NCT00750295
First Posted
September 9, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00750295
Brief Title
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease,, hemodialysis,, serum phosphorus,, phosphate binders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Intervention Type
Drug
Intervention Name(s)
SBR759
Intervention Description
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Primary Outcome Measure Information:
Title
In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
Secondary Outcome Measure Information:
Title
Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis Investigator Site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2639
Description
Results for CSBR759A2101 from the Novartis Clinical Trials website
Learn more about this trial
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
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