Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule
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
Kyowa Kirin Korea Co., Ltd.
100 participants
Dec 21, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- 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
Interventions
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. It will be conducted with 13 visits over 48 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06206135