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

Recruiting

• Conditions: Hyperphosphatemia
• Interventions: Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

• Registration Number: NCT06206135
• Lead Sponsor: Kyowa Kirin Korea Co., Ltd.

Brief 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.

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 Timeline

• Study First Submitted: 2023-12-17
• Study Start: 2023-12-21
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low-dose group	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	the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)	initial dose 4 g/day

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)	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)
Mean change from baseline to week 48 in serum phosphorus level	48 weeks	Mean change from baseline to week 48 in serum phosphorus level
Initial dose retention period	Up to 48weeks	Initial dose retention period

Trial Locations

Locations (1)

Jesus Hospital; 🇰🇷 Jeonju, Korea, Republic of