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NCT Number: NCT06206135

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

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.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jesus Hospital

Jeonju, South Korea

Location status: Recruiting

Location contact

Ayeong cho

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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)

  2. Mean change from baseline to week 48 in serum phosphorus level

    Time frame: 48 weeks

    Mean change from baseline to week 48 in serum phosphorus level

  3. Initial dose retention period

    Time frame: Up to 48weeks

    Initial dose retention period

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Study Lead

CONTACT

[email protected]

82-2-6987-4112

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jan 16, 2024
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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