Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia
Brief Summary: This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.


Options:
A: 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
B: Inclusion Criteria:

* Stage III to V Chronic Kidney Disease
* Serum Phosphorus 4.0-6.0 mg/dL prior to Randomization
* Ferritin 300 ng/mL or less
* Transferrin Saturation (TSAT) 30% or less
* Hemoglobin \>9.0 and \<12.0 g/dL
* Must consume a minimum of 2 meals per day

Exclusion Criteria:

* Parathyroidectomy within 24 weeks of study
* gastrointestinal bleed or inflammatory bowel disease within 12 weeks of study
* Requirement for dialysis or kidney injury within 8 weeks of study
* Absolute requirement for oral iron, intravenous iron, Erythropoiesis-Stimulating Agent, blood transfusions, and Sensipar during the study
* Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
* Absolute requirement for vitamin C, niacin, or nicotinamide outside of multivitamins
* History of hemochromatosis
* Allergy to iron products
* History of malignancy in last 5 years
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:

* Male or female, and is \>=18 years old
* Stable hemodialysis or peritoneal dialysis
* Subjects has Stable phosphate control
* Subjects on Stabilized phosphorus diet
* Subjects undergoing regular dialysis treatment
* Female and of child-bearing potential have a negative serum pregnancy test.
* Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

* Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study.
* serum albumin level \< 3.0g/dL
* PTH level \> 1000pg/mL
* Hemoglobin level \< 8mg/dL
* A History of significant gastrointestinal motility problems
* Biliary obstruction or proven liver dysfunction
* A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
* A clinically significant severe lactose intolerance or sensitivity
* A history of substance or alcohol abuse within the last year.
* Seizure disorders
* A history of drug or other allergy
* using cholestyramine, colestipol or colesevelam
* Schedule to receive a kidney transplant within the next 6 months
* Participation in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

Answer: D