At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 68 enrolled
Drug / intervention
HS219 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
In Brief
A Phase 2 clinical trial evaluating HS219 and Placebo for Hyperphosphatemia and Chronic Kidney Disease. Completed, enrolled 68 participants across 11 sites.
Detailed Summary
This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperphosphatemia, Chronic Kidney Disease
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionMay 2010
Study CompletionJun 2010
TodayJul 2026
First PostedDec 25, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.5 years ago
Interventions
HS219dietary
Chewing for 30 min three time a day far after meal
Placebodietary
Chewing for 30 min three times a day far after meal