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

N/ARecruitingNCT06206135

Kyowa Kirin Korea Co., Ltd.100 enrolled

Overview

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.

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

100

Conditions

Hyperphosphatemia

Interventions

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.

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jesus Hospital

Jeonju, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 48 weeks

Secondary Outcomes

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

Mean change from baseline to week 48 in serum phosphorus level

Time frame: 48 weeks

Initial dose retention period

Time frame: Up to 48weeks

Central Contacts

hyeokjun choi

CONTACT

01074713471 hyeokjun.choi.2j@kyowakirin.com

Data from ClinicalTrials.gov

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