A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
- Registration Number
- NCT00750295
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 SBR759 - 2 SBR759 - 3 SBR759 - 4 SBR759 - 7 SBR759 - 5 SBR759 - 6 SBR759 -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
Trial Locations
- Locations (1)
Novartis Investigator Site
🇺🇸Denver, Colorado, United States