RecruitingNCT06186934
Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients
Sponsor
Kyowa Kirin Korea Co., Ltd.
Enrollment
600 participants
Start Date
Dec 21, 2023
Study Type
OBSERVATIONAL
Conditions
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 clinical settings
Eligibility
Min Age: 19 Years
Inclusion Criteria4
- 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 Criteria7
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGthe standard-dose group (4 g/day)
Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06186934
Related Trials
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
NCT0427840451 locations
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
NCT0693347242 locations
Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)
NCT03573089115 locations
Evaluate the Efficacy and Safety of JMKX003002 in End-Stage Renal Disease Patients on Hemodialysis with Hyperphosphatemia
NCT066641252 locations
Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
NCT062061351 location