Phase 2
N=63
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Hyperphosphatemia · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01039428 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline — -0.26; -0.20 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HS219 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- KDL Inc.
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline |
-0.26; -0.20 | — |
| SECONDARY Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL |
7; 2 | — |
| SECONDARY Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3 |
8; 2 | — |
| SECONDARY Serum Inorganic Phosphorus Level |
6.38; 6.29 | — |
| SECONDARY Salivary Inorganic Phosphorus Level |
22.32; 21.51 | — |
| SECONDARY Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL]) |
9.37; 9.13 | — |
| SECONDARY Ca×P |
59.90; 57.24 | — |
| SECONDARY Serum Intact Parathyroid Hormone (PTH) Level |
206.5; 251.2 | — |
| SECONDARY Serum Intact Fibroblast Growth Factor (FGF) 23 Level |
4.0; 4.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Written informed consent given
- Able to comply with the study procedures and medication
- On a stable HD regimen (at least 3 x per week) for ≥ 3 months
- Subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month
- A mean serum inorganic phosphorous in the previous 3 tests : > 5.5 mg/dL and < 9.0 mg/dL
- Removal rate of blood urea nitrogen (BUN) ≥ 60%
- Rate of salivary flow by Saxon test ≥ 1 g/2 min
Exclusion Criteria
- Blood purification therapy other than HD
- Current clinically significant intestinal motility disorder
- Possible parathyroid intervention during the study period
- History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia
- History of allergy against active ingredient
- Receipt of any investigational drug within 30 days of informed consent
Data sourced from ClinicalTrials.gov (NCT01039428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.