Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Definitive Phase III Study of the Effects of Ferric Citrate on Serum Phosphate in Subjects With End Stage Renal Disease
Brief Summary: The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).


Options:
A: Inclusion Criteria:

* Written informed consent given
* Able to comply with the study procedures and medication
* On a stable HD regimen (at least 3 x per week) for ≥ 3 months
* Subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month
* A mean serum inorganic phosphorous in the previous 3 tests : \> 5.5 mg/dL and \< 9.0 mg/dL
* Removal rate of blood urea nitrogen (BUN) ≥ 60%
* Rate of salivary flow by Saxon test ≥ 1 g/2 min

Exclusion Criteria:

* Blood purification therapy other than HD
* Current clinically significant intestinal motility disorder
* Possible parathyroid intervention during the study period
* History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia
* History of allergy against active ingredient
* Receipt of any investigational drug within 30 days of informed consent
B: Inclusion Criteria:

* Age\>18 years and has a diagnosis of ESRD
* On a three-times per week hemodialysis regimen
* On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
* If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
* Hct \>= 20%
* Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion Criteria:

* Is pregnant or lactating
* Clinically significant GI disorder
* Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is \<7 mg/dL)
* ferritin\>800 ng/mL
* Unstable medical condition unsuitable for the study in the opinion of investigator
* Has been treated with an investigational agent within 30 days of enrollment
* Has a history of documented iron allergy or hemochromatosis
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:

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

Answer: B