Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
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
1 other identifier
interventional
202
1 country
9
Brief Summary
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2017
Typical duration for phase_4
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2017
CompletedFirst Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJanuary 13, 2020
January 1, 2020
1.7 years
July 24, 2017
January 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with treatment-emergent adverse events (TEAEs)
13 months
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
13 months
Secondary Outcomes (1)
Serum Phosphorus
13 months
Other Outcomes (10)
Serum calcium
13 months
Intact plasma parathyroid hormone (iPTH)
13 months
Ferritin
13 months
- +7 more other outcomes
Study Arms (1)
Ferric citrate
EXPERIMENTALFerric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
Interventions
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
Keelung, 20401, Taiwan
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, 22060, Taiwan
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
Taipei, 10002, Taiwan
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Taipei, 11042, Taiwan
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 11101, Taiwan
Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Publications (1)
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.
PMID: 35239732DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mai-Szu Wu, M.D.
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2017
First Posted
August 22, 2017
Study Start
April 12, 2017
Primary Completion
December 31, 2018
Study Completion
May 31, 2019
Last Updated
January 13, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share