Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
NCT ID: NCT03256838
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
202 participants
INTERVENTIONAL
2017-04-12
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Ferric citrate
Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
Ferric Citrate
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Interventions
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Ferric Citrate
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Panion & BF Biotech Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mai-Szu Wu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Locations
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Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, , 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, Taipei Medical 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 Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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PBB00501
Identifier Type: -
Identifier Source: org_study_id
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