Hemodialysis patients with hyperphosphatemia
Conditions
Interventions
HS219
Placebo
Sponsors
Healthserve
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written consent is at age 20 years or over 2. On a stable hemodialysis regimen (at least 3 x per week) for >= 3 months prior to informed consent 3. Subject receiving calcium carbonate or sevelamer hydrochloride alone as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month prior to informed consent 4. A mean value of the latest three serum phosphate levels before hemodialysis at the maximum intervals is > 5.5 mg/dL and < 9.0 mg/dL
Exclusion criteria
Exclusion criteria: 1. Blood purification therapy other than hemodialysis 2. Current clinically significant intestinal motility disorder 3. Possible parathyroid intervention during the study period 4. History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia 5. Receipt of any investigational drug within 30 days of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum phosphate change compared to placebo from baseline to day 21 when measured prior to hemodialysis at the maximum intervals. | — |
Countries
Japan
Outcome results
None listed