Status:
RECRUITING
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
Lead Sponsor:
Kyowa Kirin Korea Co., Ltd.
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
19+ years
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 condit...
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 ...
Eligibility Criteria
Inclusion
- Adults 19 years of age or older as of the ICF date
- 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
- Patients who voluntarily decide to participate in this study and complete the ICF
Exclusion
- Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
- Those who require concomitant administration of aluminum-containing medication
- Others determined by the investigator to be unsuitable for participation in this study
Key Trial Info
Start Date :
December 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06206135
Start Date
December 21 2023
End Date
December 31 2025
Last Update
April 29 2024
Active Locations (1)
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1
Jesus Hospital
Jeonju, South Korea