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

Hyperphosphatemia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06206135
• Other study ID #: KKKR-Nephoxil OS-01
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: hyeokjun choi
• Phone: 01074713471
• Email: hyeokjun.choi.2j[@]kyowakirin.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperphosphatemia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Jesus Hospital	Jeonju

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mean change from baseline to week 48 in serum phosphorus level	Mean change from baseline to week 48 in serum phosphorus level	48 weeks
Secondary	Initial dose retention period	Initial dose retention period	Up to 48weeks