search
Back to results

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

Primary Purpose

Kidney Failure, Chronic, End-stage Renal Disease, Phosphorus Metabolism Disorders

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Ferric Citrate
Sponsored by
Panion & BF Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Kidney Failure, Chronic focused on measuring Citric Acid, Ferric Compounds, Renal Insufficiency, Anticoagulants, Calcium Chelating Agents, Chelating Agents, Sequestering Agents, Hemodialysis, Dialysis, Renal Failure, Kidney Failure, Urologic Diseases, Metabolic Disease, Kidney Diseases, Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
  • Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
  • Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
  • Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
  • Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
  • Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
  • Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
  • Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ferric citrate

Arm Description

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

Outcomes

Primary Outcome Measures

Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

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.

Full Information

First Posted
July 24, 2017
Last Updated
January 9, 2020
Sponsor
Panion & BF Biotech Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03256838
Brief Title
Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panion & BF Biotech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, End-stage Renal Disease, Phosphorus Metabolism Disorders, Hyperphosphatemia
Keywords
Citric Acid, Ferric Compounds, Renal Insufficiency, Anticoagulants, Calcium Chelating Agents, Chelating Agents, Sequestering Agents, Hemodialysis, Dialysis, Renal Failure, Kidney Failure, Urologic Diseases, Metabolic Disease, Kidney Diseases, Renal Insufficiency, Chronic

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ferric citrate
Arm Type
Experimental
Arm Description
Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
Intervention Type
Drug
Intervention Name(s)
Ferric Citrate
Other Intervention Name(s)
Nephoxil® Capsules
Intervention Description
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Primary Outcome Measure Information:
Title
Number of subjects with treatment-emergent adverse events (TEAEs)
Description
Number of subjects with treatment-emergent adverse events (TEAEs)
Time Frame
13 months
Title
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Description
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Serum Phosphorus
Description
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.
Time Frame
13 months
Other Pre-specified Outcome Measures:
Title
Serum calcium
Description
Time-course changes of serum calcium from baseline.
Time Frame
13 months
Title
Intact plasma parathyroid hormone (iPTH)
Description
Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.
Time Frame
13 months
Title
Ferritin
Description
Time-course changes of ferritin from baseline.
Time Frame
13 months
Title
Transferring saturation (TSAT) percentage
Description
Time-course changes of transferring saturation (TSAT) percentage from baseline.
Time Frame
13 months
Title
Serum iron
Description
Time-course changes of serum iron from baseline.
Time Frame
13 months
Title
Total iron-binding capacity (TIBC)
Description
Time-course changes of total iron-binding capacity (TIBC) from baseline.
Time Frame
13 months
Title
Hemoglobin
Description
Time-course changes of hemoglobin from baseline.
Time Frame
13 months
Title
Dose of IV iron
Description
Time-course changes of dose of IV iron from baseline.
Time Frame
13 months
Title
Dose of erythropoiesis stimulating agents (ESA)
Description
Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.
Time Frame
13 months
Title
Treatment adherence
Description
Prescribed dose and the dose actually taken at each time point will be calculated.
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is ≧ 18 years of age on the day of signing informed consent or other age required by local regulation Willing and able to provide written informed consent ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment Visit 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: 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 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 Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment Is currently pregnant or breastfeeding Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai-Szu Wu, M.D.
Organizational Affiliation
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
11042
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
11101
Country
Taiwan
Facility Name
Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35239732
Citation
Lee CT, Lee CC, Wu MJ, Chiu YW, Leu JG, Wu MS, Peng YS, Wu MS, Tarng DC. Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial. PLoS One. 2022 Mar 3;17(3):e0264727. doi: 10.1371/journal.pone.0264727. eCollection 2022.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs