Kidney Failure, ChronicPhase 4NCT03256838
Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
A Phase 4 study testing Ferric Citrate in people with Kidney Failure, Chronic and End-stage Renal Disease, run by Panion & BF Biotech Inc. at 9 sites in Taiwan.
Trial summary
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, End-stage Renal Disease, Phosphorus Metabolism Disorders
- What is being tested?
- Ferric Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 9 sitesTaiwan
- Study dates
- 12 Apr 2017to 31 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Taiwan9 sites
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, 83301
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
Keelung, 20401
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, 22060
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, 40705
Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
Taipei, 10002
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Taipei, 11042
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 11101
Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
Taipei, 11217
About this study
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
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
Read the 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.
- Conditions
- Kidney Failure, Chronic, End-stage Renal Disease, Phosphorus Metabolism Disorders, Hyperphosphatemia
- Being tested
- Ferric Citrate
- 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
- Medical subject headings
- Kidney Failure, Chronic, Phosphorus Metabolism Disorders, Hyperphosphatemia, Renal Insufficiency, Urologic Diseases, Metabolic Diseases, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric CitrateDrug
Also called Nephoxil® Capsules
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
| Study group | Role | What they receive |
|---|---|---|
| Ferric citrate | Experimental | Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals). Receives: Drug: Ferric Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with treatment-emergent adverse events (TEAEs)
Measured: 13 months
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Measured: 13 months
Secondary outcomes (1)
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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start12 Apr 2017
- Primary completion31 Dec 2018
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panion & BF Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mai-Szu Wu, M.D., Principal investigator, Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256838
- Sponsor's protocol ID
- PBB00501
- Status last verified
- Jan 2020
- First submitted
- 24 Jul 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35239732
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03256838
- Acronym / sponsor ID
- PBB00501
- Conditions
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Panion & BF Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferric citrate | Experimental | Drug: Ferric CitrateFerric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric CitrateAlso: Nephoxil® CapsulesFerric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels. | Drug | Ferric citrate |
Primary outcome
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 13 months
Number of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 13 months
Percentage of subjects with treatment-emergent adverse events (TEAEs)
1 secondary outcome
Serum Phosphorus
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Derived from this study: PubMed 35239732Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai-Szu Wu, M.D. principal investigator
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric Citrate in people with Kidney Failure, Chronic and End-stage Renal Disease, run by Panion & BF Biotech Inc. at 9 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with treatment-emergent adverse events (TEAEs) (time frame: 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03256838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.