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

Phase 4

Completed

• Conditions: Kidney Failure, Chronic; End-stage Renal Disease; Hyperphosphatemia; Phosphorus Metabolism Disorders
• Interventions: Drug: Ferric Citrate

• Registration Number: NCT03256838
• Lead Sponsor: Panion & BF Biotech Inc.

Brief Summary

To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.

Detailed Description

This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-08-20
• Study First Posted: 2017-08-22
• Primary Completion: 2018-12-31
• Study Completion: 2019-05-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ferric citrate	Ferric Citrate	Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).

Primary Outcome Measures

Name	Time	Method
Number of subjects with treatment-emergent adverse events (TEAEs)	13 months	Number of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)	13 months	Percentage of subjects with treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Serum Phosphorus	13 months	Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (\>=3.5 mg/dL and \<=5.5. mg/dL) from baseline to the end-of-treatment.

Trial Locations

Locations (9)

Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital; 🇨🇳 Keelung, Taiwan

Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan

Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital; 🇨🇳 Taipei, Taiwan

Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan