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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: hyeokjun choi; Phone Number: 01074713471; Email: hyeokjun.choi.2j@kyowakirin.com

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Recruiting
    • Jesus Hospital
    • Contact: Ayeong cho; Email: loveharuka@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Hyperphosphatemia in patients with CKD undergoing hemodialysis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low-dose group; initial dose 1.5 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.
standard-dose group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	48 weeks
Initial dose retention period	Initial dose retention period	Up to 48weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin Korea Co., Ltd.
• Investigators: Study Director: hyeokjun choi, Kyowa Kirin Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: KKKR-Nephoxil OS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No