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Recruiting NCT06206135

NCT06206135 Multicenter, Open, Prospective, 48 Weeks, Observational Study ,Evaluate the Safety and Efficacy of Nephoxil Capsule

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Clinical Trial Summary
NCT ID NCT06206135
Status Recruiting
Phase
Sponsor Kyowa Kirin Korea Co., Ltd.
Condition Hyperphosphatemia
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2023-12-21
Primary Completion 2025-12-31

Trial Parameters

Condition Hyperphosphatemia
Sponsor Kyowa Kirin Korea Co., Ltd.
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 19 Years
Max Age N/A
Start Date 2023-12-21
Completion 2025-12-31
Interventions
the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

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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.

Eligibility Criteria

Inclusion Criteria: 1. Adults 19 years of age or older as of the ICF date 2. 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 3. Patients who voluntarily decide to participate in this study and complete the ICF Exclusion Criteria: 1. Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval 2. Those who require concomitant administration of aluminum-containing medication 3. Others determined by the investigator to be unsuitable for participation in this study

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