| Trial ID: | L0242 |
| Source ID: | NCT00750295
|
| Associated Drug: |
Sbr759
|
| 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
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: SBR759|DRUG: SBR759|DRUG: SBR759|DRUG: SBR759|DRUG: SBR759|DRUG: SBR759|DRUG: SBR759
|
| Outcome Measures: |
Primary: 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: Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-02
|
| Completion Date: |
2008-01
|
| Results First Posted: |
|
| Last Update Posted: |
2020-12-19
|
| Locations: |
Novartis Investigator Site, Denver, Colorado, 80230, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00750295
|
