Please select the eligibility criteria that correspond to the clinical trial below.
Title: Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Brief Summary: The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.


Options:
A: Inclusion Criteria:

1. Patients with a GFR of \< 45 ml/min;
2. Intact serum PTH \> 37 pg/ml;
3. Age \> 35 years (both genders and all races);
4. Able to perform two three-week balance studies;
5. Not on oral calcium or vitamin D other than multi vitamin, or willing to stop calcium or vitamin D for one month prior to entry in the study (day 1 of first calcium balance period);
6. Female patients must be post-menopausal (defined as last menstrual period at least 12 months prior to screening visit) or surgically sterile by hysterectomy;
7. On stable doses of diuretics, bisphosphonates, anti-epileptics (except dilantin) for at least 2 months.

Exclusion Criteria:

1. Serious underlying systemic disease (including uncontrolled diabetes, lupus, hypertension, amyloid, etc);
2. Taking drugs that alter calcium and phosphate balance or homeostasis including high dose cholecalciferol or ergocalciferol (1000 U/day or 50,000U/ wk, respectively), active vitamin D metabolites, calcimimetics, PTH analogues in the last 30 days;
3. Taking drugs that the investigator feels will alter calcium balance;
4. Plan to initiate dialysis in the next six months;
5. Hypercalcemia defined as serum calcium \> 10.5 mg/dl;
6. Hyperphosphatemia defined as serum phosphate \>5.5mg/ml;
7. Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, bariatric surgery;
8. Smoking
B: Inclusion Criteria:

* Under a physician's care for CKD for \> 2 months and are not expected to begin dialysis for 4 months
* Screening estimated GFR of 15-59 mL/1.73 m2
* Serum phosphorus \>= 4.7 mg/d following washout

Exclusion Criteria:

* Requiring treatment with cinacalcet HCI or compounds containing phosphate, aluminum, calcium or magnesium
* Rapidly progressing glomerulonephritis
* Cirrhosis or other clinically significant liver diseases
* Past or present uncontrolled peptic ulcer, Crohn's disease, malignancy or recent GI bleed
C: 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
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: C