Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief 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.


Options:
A: 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
B: Inclusion Criteria:

* Men or women greater than 18 years of age.
* The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB).

Exclusion Criteria:

* Receiving hemodialysis.
* Receiving or has received an investigational product (or is currently using an investigational device) within 28 days prior to Visit 2.
* Evidence of active and clinically significant infection at Visit 2.
* Dental work within 48 hours prior to Visit 2.
C: Inclusion Criteria:

* Renal failure stage 3B
* 25(OH)vitamin D level above 50 nmol/l
* Age over 18 years
* Written consent

Exclusion Criteria:

* Major surgery during the previous 6 months
* Myocardial infarct during the previous 6 months
* Unstable heart failure
* Ongoing treatment for any malignancy
* History of frequent infections
* Pregnancy
* Ongoing treatment with steroids, lithium or biphosphonates
D: Inclusion Criteria:

* Eligible subjects will be male or female patients with end-stage renal disease on maintenance hemodialysis for less than 5 years, with elevated LDL cholesterol
* Currently treated with oral phosphate binders
* Coronary artery calcium scores of 30 to 5000 Agatston units measured by electron beam CT scanning
* Written informed consent
* Negative serum pregnancy test if appropriate
* Expect to comply with protocol procedures and schedule

Exclusion Criteria:

* Unstable angina pectoris
* Severe congestive heart failure
* Severe obstructive pulmonary disease requiring supplemental oxygen
* Severe liver dysfunction
* Severe malnutrition
* Severe hyperparathyroidism
* Known HIV
* Active malignancy for which the subject is receiving chemotherapy or radiation
* Planned renal transplant within the next year
* Clinical evidence of calciphylaxis or recent history of hypercalcemia
* History of obstructed bowels
* Hypersensitivity to any of the components of the study medication
* History of swallowing disorders
* Weight \> 300 pounds
* Any condition which makes patient participation not in the patient's best interest

Answer: A