Multicenter, randomized, placebo- controlled, double blind study of HS219 to evaluate the efficacy and safety in chronic kidney disease patients on hemodialysis with hyperphosphatemia
- Conditions
- Hemodialysis patients with hyperphosphatemia
- Registration Number
- JPRN-UMIN000002840
- Lead Sponsor
- Healthserve
- Brief Summary
Sixty eight HD patients maintained on calcium carbonate (33 subjects) or sevelamer (35 subjects) were enrolled during January - April, 2010. Sixty-three patients chewed at least one gum: 35 HS219 and 28 placebo. HS219 was well tolerated and safe. However, no significant effect of HS219 on reduction of serum phosphorous was observed. There were no significant differences between HS219 and placebo in the ratio of 1.5 mg/dL of reduction of serum phosphorus level and the rate of achievement to the targeted serum phosphorus level; &#8805; 3.5 mg/dL and < 5.5 mg/dL. There were no significant effects of HS219 on change of salivary phosphorus, serum Ca, serum Ca x P, iPTH and EGF 23.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 64
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum phosphate change compared to placebo from baseline to day 21 when measured prior to hemodialysis at the maximum intervals.
- Secondary Outcome Measures
Name Time Method