Please select the eligibility criteria that correspond to the clinical trial below.
Title: EPIC (Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease): A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel Arm, Study of PhosLo on Phosphorus Levels in Subjects With Chronic Kidney Disease
Brief Summary: The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.


Options:
A: 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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B: Inclusion criteria:

1. Men or women of at least 18 years of age
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria:

1. Patients who are on peritoneal dialysis
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin \> 1000 ng/mL
7. Transferrin saturation \> 60%
8. Uncontrolled hyperparathyroidism (iPTH \> 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply
C: Inclusion criteria

* Men or women of at least 18 years old or 20 years old in Japan.
* Stable maintenance of hemodialysis 3 times per week.
* Controlled serum phosphate if under phosphate-binder therapy.
* Serum phosphate level \> 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

* Peritoneal dialysis or a non-conventional hemodialysis technique .
* Parathyroidectomy or transplant scheduled during the study.
* Uncontrolled hyperparathyroidism
* History of hemochromatosis or ferritin \> 800 µg/L.
* Clinically significant GI disorder
* Unstable medical condition other than Chronic Kidney Disease.
* Treated with sevelamer HCl monotherapy or SBR759.
* Treated with oral iron.
* Other protocol-defined inclusion/exclusion criteria may apply.
D: Inclusion Criteria:

* Non-dialyzed male or female patients with CKD, with a GFR of less than 30mL/min/1.73m² who have elevated serum phosphorus or who develop elevated serum phosphorus following washout from phosphorus-binding therapy.
* Patients must have written informed consent
* Negative serum pregnancy test if appropriate
* Expected to be able to comply with protocol procedures and schedule

Exclusion Criteria:

* Unstable angina pectoris
* Severe congestive heart failure
* Severe liver dysfunction
* Severe malnutrition
* Severe hyperparathyroidism
* AIDS (HIV positive subjects without AIDS are not excluded)
* Active malignancy for which the subject is receiving chemotherapy or radiation
* Subject unlikely to complete the study
* History of obstructed bowels or hypersensitivity to any of the study medications or their components
* History of swallowing disorders such as dysphagia (that would prevent the subject from taking the study drug) severe gastrointestinal motility disorders, or major GI tract surgery
* Participation in an investigational drug or device trial within 30 days of randomization
* Subjects on Vitamin D therapy
* Subjects with acute symptoms, in the last month, or current radiographic evidence of kidney stones
* Subjects who have undergone renal transplant or receiving dialysis
* Or any condition with makes patient participation not in the patients best interest

Answer: D