Ferric Citrate in Patients With End-Stage Renal Disease on Dialysis

Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females

2. Age greater than or equal to 18 years

3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous
three months prior to Screening Visit (Visit 0)

4. Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to
8.0 mg/dL at Screening Visit (Visit 0)

5. Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (visits
2 or 3)

6. Taking 3 to 18 pills per day (or 2-10 gm) of calcium acetate, calcium carbonate,
lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent
sevelamer powder) or any other agent serving as a phosphate binder, or any
combination of these agents as reported by the patient at Screening Visit (Visit 0)

7. Serum ferritin less than 1000 micrograms/L and TSAT less than 50% at the Screening
Visit (Visit 0)

8. Willing to be discontinued from current phosphate binder(s) and initiated on ferric
citrate

9. Willing and able to give informed consent

10. Life expectancy greater than 1 year -

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening Visit (Visit 0)

2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease

3. Serum phosphorus levels greater than or equal to 10.0 mg/dL documented in the three
monthly laboratories (done routinely in the dialysis unit) in all of the 3 months
prior to the Screening Visit (Visit 0)

4. Patients with baseline ferritin levels of greater than or equal to 1000 ng/mL and
TSAT greater than or equal to 50% documented in the three monthly labs prior to the
screening visit

5. History of multiple drug allergies or intolerances

6. History of malignancy in the last five years (treated cervical or non-melanomatous
skin cancer may be permitted if approved by CCC)

7. Previous intolerance to oral ferric citrate

8. Intolerance to oral iron-containing products

9. Absolute requirement for oral iron therapy

10. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.]
allowed)

11. Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with
meals 12 Psychiatric disorder that interferes with the patients ability to comply
with the study protocol

13. Inability to tolerate oral drug intake 14. Intolerance to calcium acetate and
sevelamer carbonate 15. Planned surgery or hospitalization during the trial (for example
scheduled outpatient access surgery, eye laser surgery, etc allowed-Please contact CCC
with any question) 16. 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 17. Receipt of any investigational drug
within 30 days of Screening Visit (Visit 0) 18. Inability to cooperate with study
personnel or history of noncompliance 19. Unsuitable for this trial per Investigators
clinical judgment. -