Status:
COMPLETED
A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00750295
Start Date
February 1 2007
End Date
January 1 2008
Last Update
December 19 2020
Active Locations (1)
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1
Novartis Investigator Site
Denver, Colorado, United States, 80230