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Completed

NCT Number: NCT01039428

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

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.

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Key information

Conditions

Hyperphosphatemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Meiyo Clinic, Toyohashi, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HS219

Dietary Supplement

Chewing for 30 min three time a day far after meal

Placebo

Dietary Supplement

Chewing for 30 min three times a day far after meal

Primary outcomes

  1. 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

    Change in serum inorganic phosphorus at the end of treatment from baseline

Secondary outcomes

  1. Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL

    Time frame: baseline and end of the treatment

  2. Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3

    Time frame: week 3

  3. Serum Inorganic Phosphorus Level

    Time frame: week 3

    Serum inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  4. Salivary Inorganic Phosphorus Level

    Time frame: week 3

    Salivary inorganic phosphorus levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  5. 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

    Serum Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  6. Ca×P

    Time frame: week 3

    Serum inorganic phosphorus and Ca levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  7. Serum Intact Parathyroid Hormone (PTH) Level

    Time frame: week 3

    Serum intact and whole PTH levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

  8. Serum Intact Fibroblast Growth Factor (FGF) 23 Level

    Time frame: week 3

    Serum intact FGF23 levels were determined at week 3 before the first dialysis of the week (Monday or Tuesday).

Sponsors and collaborators

Lead sponsor

KDL Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 25, 2009
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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