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Clinical Trials in South Korea / NCT06206135
Recruiting Observational

Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule

NCT06206135 · tracked via the Priya Life Science South Korea tracker
Sponsor
LG Chem
Phase
Observational
Started
2023-12-21
Last updated
2026-09-03

Condition(s) studied

Hyperphosphatemia

Investigational drug(s) / intervention(s)

the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

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.

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Adults 19 years of age or older as of the ICF date 2. 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 3. Patients who voluntarily decide to participate in this study and complete the ICF Exclusion Criteria: 1. Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval 2. Those who require concomitant administration of aluminum-containing medication 3. Others determined by the investigator to be unsuitable for participation in this study

Primary outcome measure(s)

  • Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48 — 48 weeks
    Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48

Trial sites (1)

FacilityCityRegionStatus
Jesus Hospital Jeonju South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06206135 on ClinicalTrials.gov ↗ ← All trials in South Korea