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

Kyowa Kirin

Status: Enrolling

Conditions: Hyperphosphatemia

Treatments: Drug: the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

Study type: Observational

Funder types: Industry

Identifiers

NCT06206135

KKKR-Nephoxil OS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

low-dose group

Description:

initial dose 1.5 g/day

Treatment:

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

standard-dose group

Description:

initial dose 4 g/day

Treatment:

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