Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Dietary Protein Source on Phosphaturia, PTH and FGF23 in Patients With CKD 3 and 4
Brief Summary: Phosphorus is a substance in the blood that comes from food and is normally cleared from the body by the kidneys. In patients with kidney disease, excess phosphorus may build up in the body as you eat. This leads to problems with bones and blood vessels over time. In this study, we will compare the blood and urine before and after eating one week of a diet with a protein from plants (soy and grains) and before and after another one week of diet with protein from animals (meat and dairy products). The amount of phosphorus that the kidney puts out in the urine, and the changes in blood hormones in response to the diet will be measured at the beginning and end of each week on the two diets.


Options:
A: Inclusion Criteria:

* age \>18 years
* eGFR 20-45 by modified MDRD equation
* protein/creatinine ratio \<5
* blood pressure \<150/95
* not taking calcium binder or supplements, vitamin D, or phosphate binders
* normal serum phosphorus and calcium corrected for albumin and intact PTH \<100pg/ml
* medically stable
* able to give informed consent and come for all visits

Exclusion Criteria:

* history of significant liver disease or cirrhosis
* medically unstable
* unable to tolerate diets
B: 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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C: 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.
D: 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

Answer: A