A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis

A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

This is up to a 58 week study comparing ferric citrate to active control for 52 weeks in ESRD dialysis patients, and subsequently comparing ferric citrate to placebo for 4 weeks.

This trial is a three-period, multicenter, safety and efficacy clinical trial. The first period is a two-week Washout Period, the second period is a 52-week randomized, open-label, active control Safety Assessment Period, and the third period is a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period in only the patients who were randomized to treatment with ferric citrate during the Safety Assessment Period. The primary objectives of this trial are to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with ESRD undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in the four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period.

Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females
2. Age ≥18 years
3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening
4. Serum phosphorus ≥6.0 mg/dL for study entry
5. Taking less than 3-18 pills/day of current phosphate binder
6. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate
7. Willing and able to give informed consent
8. Life expectancy >1 year

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening
2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
3. History of multiple drug allergies or intolerances
4. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)
5. Previous intolerance to oral ferric citrate
6. Intolerance to oral iron-containing products
7. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
8. Inability to tolerate oral drug intake
9. Intolerance to calcium acetate and sevelamer carbonate
10. 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
11. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)
12. Inability to cooperate with study personnel or history of noncompliance
13. Unsuitable for this trial per Investigator's clinical judgment.