Overview

Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

Status:
Completed
Trial end date:
2019-05-31
Target enrollment:
0
Participant gender:
All
Summary
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Panion & BF Biotech Inc.
Treatments:
Chelating Agents
Citric Acid
Ferric Compounds
Criteria
Inclusion Criteria:

1. Is ≧ 18 years of age on the day of signing informed consent or other age required by
local regulation

2. Willing and able to provide written informed consent

3. ESRD patients who is undergoing hemodialysis 3 times per week and is considered
necessary to receive medication for hyperphosphatemia by his/her treating physician

4. Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment
Visit

5. Women of child-bearing potential (WOCBP [defined as women ≤ 50 years of age with a
history of amenorrhea for < 12 months prior to study entry]) who is willing to use an
effective form of contraception during study participation

Exclusion Criteria:

1. Has any known contraindication to ferric citrate according to locally approved
prescribing information, include but not limited to the following criteria:

i. Is allergic to ferric citrate ii. Has hypophosphatemia iii. Has hemochromatosis or
iron overload syndromes iv. Has active severe GI disorders

2. Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3
months prior to Enrollment Visit or serum calcium < 7 mg/dL at the Enrollment Visit

3. Has participated in another interventional study for any investigational agent or
device within 30 days prior to enrollment

4. Is currently pregnant or breastfeeding

5. Other unstable medical condition or psychiatric conditions that is considered
unsuitable for this study per Investigator's clinical judgment