Status:
RECRUITING
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
Lead Sponsor:
Kyowa Kirin Korea Co., Ltd.
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
19+ years
Brief Summary
The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine ...
Eligibility Criteria
Inclusion
- Adults 19 years of age or older
- CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
- Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
- Those (or his / her legal guardian) who have agreed in writing to participate in the survey
Exclusion
- Patients with contraindications to receive Nephoxil
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with hypophosphatemia
- Patients with abnormal iron metabolism or symptoms of excessive iron (e.g. hemochromatosis)
- Patients who intend to use this drug for non-approved indications
- Patients who participated in pre-market clinical trials with Nephoxil
- Patients who took this drug before the starting day of this survey
Key Trial Info
Start Date :
December 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06186934
Start Date
December 21 2023
End Date
January 30 2026
Last Update
April 29 2024
Active Locations (1)
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1
Jesus Hospital
Jeonju, South Korea