Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phosphorus Improvement Pilot Study
Brief Summary: Specific Aim: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels.

Hypothesis: Educating dialysis patients regarding phosphate containing additives will result in improved serum phosphorus levels.


Options:
A: Inclusion Criteria:

* Most recent phosphorus and mean phosphorus over last 3 months \> 5.5 mg/dL
* Age ≥ 18 years
* On chronic hemodialysis ≥ 6 months
* English speaking

Exclusion Criteria:

* Mentally incompetent
* AIDS
* Cancer
* Terminal illness
* Pregnancy
* Nursing home residence
* No telephone access
* In another phosphorus related study
* Unable to identify written words
B: 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
C: Inclusion Criteria:

1. Men or women \> 18 years of age;
2. The subject has voluntarily signed and dated the most recent informed consent form approved by an Institutional Review Board (IRB);
3. The subject will, in the opinion of the investigator, be compliant with prescribed therapy and all study visits;
4. Subject must be able to communicate and be able to understand and comply with the requirements of the study;
5. For subjects not on dialysis estimated GFR at screening \< or equal to 60 ml/min + 10 % that in the opinion of the investigator is stable and not expected to initiate dialysis within 3 months;
6. Subject must have serum phosphorus at screening of greater than or equal to 3.5 mg/dL;
7. Subjects must have a screening salivary flow rate by Saxon test ≥ 1 g/2 min;
8. All subjects must have NO change in prescribed dose or frequency of any of the following medications ≥ 14 days prior to Run-In Visit 2 (Day -15):

a. Phosphate binding products including prescribed and over-the counter b. Oral or injectable active vitamin D c. Oral nutritional vitamin D d. Calcium supplements e. Anti-osteoporotic medication (e.g. bisphosphonates) f. Cinacalcet i. Subject must be prescribed a diet appropriate for patients with their stage of CKD, must be willing to avoid intentional changes in diet and must have stable nutritional status in the opinion of the investigator.

j. Subjects on dialysis must, in the opinion of the investigator, have a stable dialysis prescription, stable dialysis access and a URR \>/= 65% for at least 4 weeks prior to Day -15.

Exclusion Criteria:

1. Subject is receiving or has received an investigational product (or is currently using an investigational device) within 14 days prior to Visit 2 (Day -15);
2. Subject has a known sensitivity to chitin or allergy to shellfish;
3. Subject has had dental work other than cleaning, cavity filling or crown placement within 48 hours prior to Visit 4 (Day 1) or at any time during the course of the trial;
4. Subject has a clinically significant infection requiring treatment with antibiotics (within 7 days prior to Visit 2 (Day -15));
5. Subject has had an inpatient hospitalization within 14 days prior to Visit 2 (Day -15) with the exception of hospitalizations related to vascular access procedures;
6. Subject has a known history of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result;
7. Active drug or alcohol dependence or abuse (excluding tobacco use) in the opinion of the principal investigator;
8. In the opinion of the investigator, subject is unable to chew gum for 30 minutes;
9. Subject has an unstable medical condition which in the opinion of the investigator would compromise successful completion of the study;
10. Subject is receiving calcimimetic therapy (acceptable if subject is on dialysis);
11. Subject has known salivary gland dysfunction or Sjogren's syndrome;
12. Subjects is receiving niacin therapy within 7 days prior to Run- In Visit 2(Day -15) (use as part of standard multivitamin is acceptable);
13. Subject has had a major cardiovascular event within 90 days of screening. The investigator should be guided by evidence of any of the following;

a. Acute myocardial infarction b. Acute cerebral vascular event c. Vascular surgical intervention d. Coronary Revascularization e. Decompensated congestive heart failure

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D: 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

Answer: A