Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis
Brief Summary: This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis


Options:
A: 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.
B: Inclusion Criteria:

Subjects meeting all of the criteria listed below may be included in the study:

1. ≥18 years old.
2. Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
3. Been in the care of a physician for CKD for \>2 months, and are not expected to begin dialysis for at least 6 months.
4. Screening serum c-terminal FGF23 \> 50.0RU/mL.
5. Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
6. Normal serum phosphate (0.808-1.55mmol/L).
7. Endogenous 25-hydroxy Vitamin D levels \>20ng/mL.
8. Adequate protein diet (includes 2-3 portions of protein-rich food per day).
9. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
10. Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion Criteria

1. Vitamin D supplementation required.
2. Compounds containing calcium, phosphate, aluminium or magnesium required.
3. Acute renal failure.
4. Rapidly progressing glomerulonephritis.
5. Vegetarian diet.
6. Known allergy to iodine.
7. Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
8. Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) \>3 times the upper limit of normal or bilirubin \>2 times the upper limit of normal).
9. Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
10. Life-threatening malignancy or current multiple myeloma.
11. Known to be Human Immunodeficiency Virus (HIV) positive.
12. History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
13. History of alcohol or other substance abuse within 6 months prior to screening.
14. Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
15. Subjects who have previously been enrolled into this study and subsequently withdrawn.
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:

* Stable CKD patients who are currently on hemodialysis three times a week for at least 12 weeks prior to the acquisition of informed consent
* Patients on stable dose(s) of phosphate binder(s) for at least 28 days prior to the acquisition of informed consent.
* Patients on stable dose(s) of Vitamin D or calcitonin agent for at least 28 days prior to the acquisition of informed consent, in case patients are treated by those agents

Exclusion Criteria:

* History of major gastrointestinal surgery, or swallowing disorders, bowel obstruction, hemorrhagic gastrointestinal lesion
* Continuous severe constipation/diarrhea.
* History of parathyroid intervention \[parathyroidectomy（PTx），percutaneous ethanol injection therapy（PEIT）etc.\] within 1 year of the acquisition of informed consent
* Diet restriction such as fasting and/or excessive dieting
* Uncontrolled hypertension

Answer: C