A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KDL Inc.
ClinicalTrials.gov Identifier:
NCT01039428
First received: December 24, 2009
Last updated: June 5, 2012
Last verified: May 2012

December 24, 2009
June 5, 2012
December 2009
May 2010   (final data collection date for primary outcome measure)
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline [ Time Frame: baseline and end of the chewing treatment during three week treatment period ] [ Designated as safety issue: No ]
Change in serum inorganic phosphorus at the end of treatment from baseline
Change in serum inorganic phosphorus [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01039428 on ClinicalTrials.gov Archive Site
  • Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL [ Time Frame: baseline and end of the treatment ] [ Designated as safety issue: No ]
  • Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
  • Serum Inorganic Phosphorus Level [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
  • Salivary Inorganic Phosphorus Level [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
  • 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]) [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
  • Ca×P [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
  • Serum Intact Parathyroid Hormone (PTH) Level [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
  • Serum Intact Fibroblast Growth Factor (FGF) 23 Level [ Time Frame: week 3 ] [ Designated as safety issue: No ]
    Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).
  • Serum inorganic phosphorus reduction of 1.5 mg/dL [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Achievement rate of serum inorganic phosphorus; 3.5 ≦P<5.5 mg/dL [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in serum inorganic phosphorus level by time [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in salivary inorganic phosphorus level by time [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in corrected serum Ca level [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in Ca×P [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change in intact PTH and whole PTH [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hyperphosphatemia
  • Chronic Kidney Disease
  • Dietary Supplement: HS219
    Chewing for 30 min three time a day far after meal
  • Dietary Supplement: Placebo
    Chewing for 30 min three times a day far after meal
  • Experimental: HS219
    Intervention: Dietary Supplement: HS219
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Akizawa T, Tsuruta Y, Okada Y, Miyauchi Y, Suda A, Kasahara H, Sasaki N, Maeda Y, Suzuki T, Matsui N, Niwayama J, Suzuki T, Hara H, Asano Y, Komemushi S, Fukagawa M. Effect of chitosan chewing gum on reducing serum phosphorus in hemodialysis patients: a multi-center, randomized, double-blind, placebo-controlled trial. BMC Nephrol. 2014 Jun 25;15:98. doi: 10.1186/1471-2369-15-98.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
June 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01039428
HS219CCR-001
Yes
KDL Inc.
KDL Inc.
Not Provided
Study Chair: Tadao Akizawa, MD Divison of Nephrology, Department of Medicine, Showa University School of Medicine
Study Director: Masafumi Fukagawa, MD, PhD Divison of Nephrology and Metabolism, Tokai University School of Medicine
KDL Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP