A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2007
1 active site
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
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedDecember 19, 2020
August 1, 2011
11 months
September 9, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
Study Arms (7)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTAL5
EXPERIMENTAL6
EXPERIMENTAL7
EXPERIMENTALInterventions
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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigator Site
Denver, Colorado, 80230, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Novartis Investigator Site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2008
First Posted
September 10, 2008
Study Start
February 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
December 19, 2020
Record last verified: 2011-08