Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Lanthanum Carbonate for the Reduction of Serum Phosphorus in Subjects With Stage 3 and 4 Chronic Kidney Disease Who Have Elevated Serum Phosphorus Levels
Brief Summary: Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.


Options:
A: 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
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:

* Males or non-pregnant, non-lactating females
* Age \> 18 years
* On thrice weekly hemodialysis or peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0)
* Serum phosphorus levels ≥ 3.5 mg/dL and \< 8.0 mg/dL at Screening Visit (Visit 0)
* Serum phosphorus levels \> 6.0 mg/dL during the washout period (Visits 2 or 3)
* Taking 3 to 15 tablets/capsules per day of 667mg calcium acetate or 800 mg sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at Screening Visit (Visit 0)
* Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50% at the Screening Visit (Visit 0)
* Willingness to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
* Willing and able to give informed consent
* Willing and able to stay on a constant dose of Vitamin D (or its analogs) and Sensipar (cinacalcet) for the treatment period, if applicable.

Exclusion Criteria:

* Parathyroidectomy within six months prior to Screening Visit (Visit 0)
* Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
* Serum phosphorus levels \>10.0 mg/dL documented in all of the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
* History of multiple drug allergies or intolerances
* History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
* Previous intolerance to oral ferric citrate
* Absolute requirement for oral iron therapy
* Absolute requirement for Vitamin C (multivitamins \[Nephrocaps, Renaphro, etc.\] allowed)
* Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
* Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
* Inability to tolerate oral drug intake
* Planned surgery or hospitalization during the trial (scheduled outpatient access surgery allowed)
* Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient
* Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
* Inability to cooperate with study personnel or history of noncompliance
* Unsuitable for this trial per Principal Investigator's clinical judgment

Answer: B