An observational study in Hyperphosphatemia, sponsored by LG Chem. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by LG Chem · Observational
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.
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.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's planned enrollment of 172 is below the median of 200 across 25 observational studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →LG Chem is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hyperphosphatemia in patients with CKD undergoing hemodialysis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
initial dose 1.5 g/day
Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)
initial dose 4 g/day
Drug: 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.
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
Time frame: 48 weeks
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)
Time frame: 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
Time frame: 48 weeks
Initial dose retention period
Initial dose retention period
Time frame: Up to 48weeks
Plan to share: Undecided — Undecided
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