Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Brief Summary: A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:

1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.


Options:
A: Inclusion Criteria:

* Dialysis patients with hyperphosphataemia (≥ 1.94 mmol/L; ≥ 6.0 mg/dL)
* Stable dose of phosphate binder
* Written informed consent

Exclusion Criteria:

* Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
* Other significant medical conditions
* Pregnancy
B: Inclusion Criteria:

* life expectancy of at least 12 months,
* patients have received hemodialysis three times per week for 3 months or longer,
* patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).

Exclusion Criteria:

* active bowel obstruction,
* dysphagia,
* swallowing disorders,
* severe gastrointestinal motility disorders,
* active ethanol or drug abuse (excluding tobacco),
* need for antidysrhythmic or antiseizure medications used to control these conditions,
* poorly controlled diabetes mellitus or hypertension,
* active vasculitis,
* active malignancy other than basal-cell carcinoma,
* HIV infection,
* any clinically significant unstable medical condition as judged by the investigator.
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:

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

Answer: B