Please select the eligibility criteria that correspond to the clinical trial below.
Title: Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?
Brief Summary: The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.


Options:
A: 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
B: 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
C: 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;
D: Inclusion Criteria:

* Chronic kidney disease patients aged 18 to 80 years
* Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60 ml/min/1.73m2)
* Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry into the study
* Total cholesterol less than 5.5 mmol/l

Exclusion Criteria:

* Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue
* Uncontrolled hyperphosphataemia (serum phosphate \>1.8 mmol/l)
* Uncontrolled secondary hyperparathyroidism (PTH \>80 pg/ml)
* Diabetes mellitus
* Pregnancy
* Moderate-severe cardiac valvular disease

Answer: D