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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03256838
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic End-stage Renal Disease Phosphorus Metabolism Disorders Hyperphosphatemia Drug: Ferric Citrate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferric citrate
Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
Drug: Ferric Citrate
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Other Name: Nephoxil® Capsules




Primary Outcome Measures :
  1. Number of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: 13 months ]
    Number of subjects with treatment-emergent adverse events (TEAEs)

  2. Percentage of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: 13 months ]
    Percentage of subjects with treatment-emergent adverse events (TEAEs)


Secondary Outcome Measures :
  1. Serum Phosphorus [ Time Frame: 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.


Other Outcome Measures:
  1. Serum calcium [ Time Frame: 13 months ]
    Time-course changes of serum calcium from baseline.

  2. Intact plasma parathyroid hormone (iPTH) [ Time Frame: 13 months ]
    Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.

  3. Ferritin [ Time Frame: 13 months ]
    Time-course changes of ferritin from baseline.

  4. Transferring saturation (TSAT) percentage [ Time Frame: 13 months ]
    Time-course changes of transferring saturation (TSAT) percentage from baseline.

  5. Serum iron [ Time Frame: 13 months ]
    Time-course changes of serum iron from baseline.

  6. Total iron-binding capacity (TIBC) [ Time Frame: 13 months ]
    Time-course changes of total iron-binding capacity (TIBC) from baseline.

  7. Hemoglobin [ Time Frame: 13 months ]
    Time-course changes of hemoglobin from baseline.

  8. Dose of IV iron [ Time Frame: 13 months ]
    Time-course changes of dose of IV iron from baseline.

  9. Dose of erythropoiesis stimulating agents (ESA) [ Time Frame: 13 months ]
    Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.

  10. Treatment adherence [ Time Frame: 13 months ]
    Prescribed dose and the dose actually taken at each time point will be calculated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256838


Locations
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Taiwan
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 80756
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
Keelung, Taiwan, 20401
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, Taiwan, 22060
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, 10002
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Taipei, Taiwan, 11042
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 11101
Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Panion & BF Biotech Inc.
Investigators
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Principal Investigator: Mai-Szu Wu, M.D. Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital

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Responsible Party: Panion & BF Biotech Inc.
ClinicalTrials.gov Identifier: NCT03256838     History of Changes
Other Study ID Numbers: PBB00501
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Panion & BF Biotech Inc.:
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
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Metabolic Diseases
Hyperphosphatemia
Phosphorus Metabolism Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Citric Acid
Sodium Citrate
Ferric Compounds
Chelating Agents
Anticoagulants
Calcium Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Hematinics