Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single Blind Pharmacodynamic Study to Assess the Phosphate Binding Characteristics of K2CG Chewing Gum
Brief Summary: The specific purpose of this study is to describe the characteristics of the K2CG chewing gum, specifically as it relates to duration of gum chewing (exposure), timing of gum chewing in relation to a meal, and dose of K2CG chewing gum.


Options:
A: Inclusion Criteria:

* Men or women \> 18 years of age;
* Must have no dietary restriction that would preclude eating standardized meal (both a meat based and vegan option available)
* The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB).
* Must be able to chew gum for at least 60 minutes.
* Must have historical eGFR appropriate for the study.

Exclusion Criteria:

* Receiving or has received an investigational product (or is currently using an investigational device) within 30 days prior to Visit 2;
* Evidence of active (clinically significant) infection at the time of study enrollment (in the opinion of the investigator);
* Dental work within 48 hours of enrollment (Visit 2); and
* Known sensitivity to chitin, or allergy to shellfish
B: Inclusion Criteria:

* Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
* Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
* Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria:

* History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
* Continuous severe constipation/diarrhea.
* History of parathyroid intervention \[parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.\] within 1 year of the acquisition of informed consent
* Diet restriction such as fasting and/or excessive dieting
* Uncontrolled hypertension
C: Inclusion Criteria:

* Stage III to V Chronic Kidney Disease
* Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
* Ferritin 300 ng/mL or less
* Transferrin Saturation (TSAT) 30% or less
* Hemoglobin \>9.0 and \<12.0 g/dL
* Must consume a minimum of 2 meals per day

Exclusion Criteria:

* Parathyroidectomy within 24 weeks of study
* gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
* Requirement for dialysis or kidney injury within 8 weeks of study
* Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
* Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
* Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
* History of hemochromatosis
* Allergy to iron products
* History of malignancy in last 5 years
D: Inclusion Criteria:

* Males or females aged between 18-70 years old
* Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
* On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria:

* Patients with hypercalcemia (corrected serum calcium \> 10.5 mg/dL)
* Any of the following abnormalities: ALT or AST \> 3X ULN; iPTH \> 1000 or \< 150 pg/mL
* History of dysphagia or swallowing disorders
* History of GI motility disorder or GI bleeding within 3 months prior to entry

Answer: A