HyperphosphatemiaNCT06206135
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
An observational study of Hyperphosphatemia, run by LG Chem at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care. 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 low-dose group (1.5 g/day) or the standard-dose group (4 g/day)
- Type of treatment
- Pill or oral medicine
- How many people
- 172 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Dec 2023to 31 Dec 2028
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hyperphosphatemia in patients with CKD undergoing hemodialysis
Who may be able to join
- Adults 19 years of age or older as of the ICF date
- CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator
- Patients who voluntarily decide to participate in this study and complete the ICF
Who cannot join
- Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
- Those who require concomitant administration of aluminum-containing medication
- Others determined by the investigator to be unsuitable for participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Jesus Hospital
Jeonju
Ayeong cho, loveharuka@naver.com
About this study
Official title: Multicenter, Open, Prospective, 48 Weeks, Observational Study in the Real-world to Evaluate the Safety and Efficacy of Nephoxil Capsule for Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.
Read the detailed description
This study is a prospective observational study, and only observable information is collected during Visits 1 to 13 of the subjects' routine outpatient visits. Therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator.
The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. During the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g.
- Conditions
- Hyperphosphatemia
- Being tested
- the low-dose group (1.5 g/day) or 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 low-dose group (1.5 g/day) or the standard-dose group (4 g/day)Drug
The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. It will be conducted with 13 visits over 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| low-dose group | initial dose 1.5 g/day Receives: Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) | |
| standard-dose group | initial dose 4 g/day Receives: Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
Measured: 48 weeks
Secondary outcomes (3)
Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)
Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)
Measured: 40 ~ 48 weeks
Mean change from baseline to week 48 in serum phosphorus level
Mean change from baseline to week 48 in serum phosphorus level
Measured: 48 weeks
Initial dose retention period
Initial dose retention period
Measured: Up to 48weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start21 Dec 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2028 (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
- 172 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suyeon Ko, Study director, LG Chem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206135
- Sponsor's protocol ID
- LG-NPXOS001
- Status last verified
- Sep 2026
- First submitted
- 17 Dec 2023
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open, Prospective, 48 Weeks, Observational Study in the Real-world to Evaluate the Safety and Efficacy of Nephoxil Capsule for Treatment of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
- ClinicalTrials.gov ID
- NCT06206135
- Acronym / sponsor ID
- LG-NPXOS001
- Conditions
- Hyperphosphatemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 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 purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.
Detailed description
This study is a prospective observational study, and only observable information is collected during Visits 1 to 13 of the subjects' routine outpatient visits. Therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator.
The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. During the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose group | – | Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)initial dose 1.5 g/day |
| standard-dose group | – | Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)initial dose 4 g/day |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hyperphosphatemia in patients with CKD undergoing hemodialysis
Key inclusion criteria (3 listed)
- Adults 19 years of age or older as of the ICF date
- CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator
- Patients who voluntarily decide to participate in this study and complete the ICF
Key exclusion criteria (3 listed)
- Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
- Those who require concomitant administration of aluminum-containing medication
- Others determined by the investigator to be unsuitable for participation in this study
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 low-dose group (1.5 g/day) or the standard-dose group (4 g/day)The initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. It will be conducted with 13 visits over 48 weeks. | Drug | low-dose group, standard-dose group |
Primary outcome
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
Time frame: 48 weeks
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
3 secondary outcomes
Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)
Time frame: 40 ~ 48 weeks
Mean change from baseline to week 48 in serum phosphorus level
Time frame: 48 weeks
Initial dose retention period
Time frame: Up to 48weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- 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.
Suyeon Ko study director
LG Chem
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 LG Chem 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Study Lead (82-2-6987-4112, lgclinical@lgchem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48 (time frame: 48 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 3 Sep 2026.