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

Kidney Failure, Chronic Clinical Trial

Official title:

A Long-Term, Open-Label, Prospective Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256838
• Other study ID #: PBB00501
• Status: Completed
• Phase: Phase 4
• Start date: April 12, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: January 2020
• Source: Panion & BF Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic
• Metabolic Diseases
• Phosphorus Metabolism Disorders
• Renal Insufficiency

Intervention

Drug:
• Ferric Citrate
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.

Locations

Country	Name	City	State
Taiwan	Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital	Kaohsiung
Taiwan	Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital	Keelung
Taiwan	Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital	New Taipei City
Taiwan	Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital	Taichung
Taiwan	Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital	Taipei
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, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Panion & BF Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum calcium	Time-course changes of serum calcium from baseline.	13 months
Other	Intact plasma parathyroid hormone (iPTH)	Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.	13 months
Other	Ferritin	Time-course changes of ferritin from baseline.	13 months
Other	Transferring saturation (TSAT) percentage	Time-course changes of transferring saturation (TSAT) percentage from baseline.	13 months
Other	Serum iron	Time-course changes of serum iron from baseline.	13 months
Other	Total iron-binding capacity (TIBC)	Time-course changes of total iron-binding capacity (TIBC) from baseline.	13 months
Other	Hemoglobin	Time-course changes of hemoglobin from baseline.	13 months
Other	Dose of IV iron	Time-course changes of dose of IV iron from baseline.	13 months
Other	Dose of erythropoiesis stimulating agents (ESA)	Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.	13 months
Other	Treatment adherence	Prescribed dose and the dose actually taken at each time point will be calculated.	13 months
Primary	Number of subjects with treatment-emergent adverse events (TEAEs)	Number of subjects with treatment-emergent adverse events (TEAEs)	13 months
Primary	Percentage of subjects with treatment-emergent adverse events (TEAEs)	Percentage of subjects with treatment-emergent adverse events (TEAEs)	13 months
Secondary	Serum Phosphorus	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.	13 months