Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 2 Week Single Blind Study to Evaluate Phosphate Binding of Chitosan Chewing Gum in Patients With Chronic Kidney Disease
Brief Summary: To determine the amount of phosphate recovered into 2 strengths of K2CG chewing gum in a modified formulation (with or without an extender) added to the gum core, in comparison to matching placebo gums.


Options:
A: Inclusion Criteria:

* Age \> 18 years
* Capable of giving informed consent
* Duration of peritoneal dialysis \> 3 months
* Dose of phosphate binder(s) stable over previous 2 week period
* Plasma phosphours \> 4.9 mg/dL based on most recent laboratory data within 1 month of enrollment

Exclusion Criteria:

* Pregnancy
* Known liver disease
* Active peptic ulcer disease
* Treatment with carbamazepine
* Intolerance to niacinamide or niacin
* Current medication regimen including niacin or niacinamide \> 100 mg daily
* Planned or expected surgical procedure in the next 4 months
* Patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given
B: Inclusion Criteria:

* Men or women \> 18 years of age;
* The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB);
* The subject will, in the opinion of the investigator, be compliant with prescribed therapy;
* Subject must be able to communicate and be able to understand and comply with the requirements of the study;
* Subject must be prescribed a diet appropriate for patients with their stage of CKD and must be willing to avoid intentional changes in diet; and
* Subject must have completed the CMD002 clinical trial and is currently receiving hemodialysis.

Exclusion Criteria:

* Subject is receiving or has received an investigational product (or is currently using an investigational device) within 7 days prior to baseline;
* Subject has a known sensitivity to chitin or allergy to shellfish;
* Subject has a clinically significant infection requiring treatment with antibiotics (within 7 days prior to baseline);
* Subject has had an inpatient hospitalization within 7 days prior to baseline with the exception of hospitalizations related to vascular access procedures; In the opinion of the investigator, subject is unable to chew gum for 60 minutes; and
* Subject has an unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
C: Inclusion Criteria:

* age \>18 years,
* CKD stage 3-5

Exclusion Criteria:

* Existing or previous treatment within the last 1 year with a phosphate binder;
* hyperphosphatemia (\>5.6 mg/dL);
* hypophosphatemia (\<2.5 mg/dL);
* malnutrition,
* malignant neoplasms,
* current history of gastrointestinal and/or endocrine diseases.
D: 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.

Answer: B