Please select the eligibility criteria that correspond to the clinical trial below.
Title: Fibroblast Growth Factor-23 Reduction in Predialysis Chronic Kidney Disease
Brief Summary: The investigators would like to study the role of phosphorus metabolism in the development of certain hormonal problems in people with chronic kidney disease (CKD). More specifically, the goals of the research are (1) to understand the cause of hyperparathyroidism - a hormone problem that often develops in patients who have kidney disease and (2) to test whether decreasing phosphorus intake could help improve or prevent hyperparathyroidism.


Options:
A: 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
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:

* 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:

* We will include stage 3a, 3b and 4 CKD patients, aged 18 years or over with normal serum phosphate levels (≤ 4.6 mg/dl)

Exclusion Criteria:

* Patients with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
* Patients expected to require dialysis initiation within the follow up period
* Patients with hyperphosphatemia \> 4.6 mg/dl
* Patients with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
* Malnutrition, defined as a serum albumin \< 3.0 mg/dl
* Patients with liver disease (ALT or AST \> 100 U/L) or cholestasis (direct bilirubin \> 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
* Anemia, defined as a hematocrit \< 27% at the screening visit
* Medical conditions impacting Pi metabolism-primary hyper- or hypoparathyroidism; Patients with previous subtotal parathyroidectomy; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or severe liver dysfunction;
* Patients with outpatient counseling by a renal nutritionist within the previous 6 months
* Hospitalization within the previous 4 weeks
* Pregnancy or breastfeeding mothers
* Patients unable to independently provide written informed consent - prisoners, mentally incompetent, minors

Answer: D