Chronic Kidney Disease
Conditions
Keywords
Chronic kidney disease,, hemodialysis,, serum phosphorus,, phosphate binders
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.
Interventions
DRUGSBR759
Four weeks of treatment with different doses of SBR759. Patients maintain their prescribed dose of other phosphate binders during the run-in period.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug. | — |
Countries
United States
Outcome results
None listed