HyperphosphatemiaNCT06186934
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
An observational study of Hyperphosphatemia, run by Kyowa Kirin Korea Co., Ltd. at 1 site in South Korea.
Trial summary
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- the standard-dose group (4 g/day)
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2023to 30 Jan 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia
Who may be able to join
- Adults 19 years of age or older
- CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
- Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
- Those (or his / her legal guardian) who have agreed in writing to participate in the survey
Who cannot join
- Patients with contraindications to receive Nephoxil
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with hypophosphatemia
- Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis)
- Patients who intend to use this drug for non-approved indications
- Patients who participated in pre-market clinical trials with Nephoxil
- Patients who took this drug before the starting day of this survey
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jesus Hospital
Jeonju
Ayeong cho, loveharuka@naver.com
About this study
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings
- Conditions
- Hyperphosphatemia
- Being tested
- the standard-dose group (4 g/day)
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the standard-dose group (4 g/day)Drug
Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus levels
Effectiveness evaluation is performed based on Serum phosphorus levels (mg/dL) before and after Nephoxil administration. We collect the most recent measurements prior to the initial administration, and measurements after at least four and eight weeks of administration of Nephoxil
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start21 Dec 2023
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186934
- Sponsor's protocol ID
- Nephoxil PMS
- Status last verified
- Apr 2024
- First submitted
- 17 Dec 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
- ClinicalTrials.gov ID
- NCT06186934
- Acronym / sponsor ID
- Nephoxil PMS
- Conditions
- Hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kyowa Kirin Korea Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 2 Jan 2024 (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.
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia
Key inclusion criteria (4 listed)
- Adults 19 years of age or older
- CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
- Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
- Those (or his / her legal guardian) who have agreed in writing to participate in the survey
Key exclusion criteria (7 listed)
- Patients with contraindications to receive Nephoxil
- Patients who intend to use this drug for non-approved indications
- Patients who participated in pre-market clinical trials with Nephoxil
- Patients who took this drug before the starting day of this survey
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 |
|---|---|---|
| the standard-dose group (4 g/day)Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia | Drug | – |
Primary outcome
Serum phosphorus levels
Time frame: 8 weeks
Effectiveness evaluation is performed based on Serum phosphorus levels (mg/dL) before and after Nephoxil administration. We collect the most recent measurements prior to the initial administration, and measurements after at least four and eight weeks of administration of Nephoxil
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia, run by Kyowa Kirin Korea Co., Ltd. at 1 site in South Korea.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hyeokjun choi (01074713471, hyeokjun.choi.2j@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphorus levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.