Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT06206135
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
Sponsor:
Kyowa Kirin Korea Co., Ltd.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: