RecruitingNCT06206135

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

Sponsor

Kyowa Kirin Korea Co., Ltd.

Enrollment

100 participants

Start Date

Dec 21, 2023

Study Type

OBSERVATIONAL

Conditions

Hyperphosphatemia

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study tracks the safety and effectiveness of a medication called Nephoxil (a phosphate binder) in people with chronic kidney disease who are on dialysis and have high phosphate levels in their blood. High phosphate is a common and serious problem for dialysis patients. **You may be eligible if...** - You are 19 or older - You have chronic kidney disease and are on hemodialysis - Your doctor has decided to start you on Nephoxil for the first time to treat high blood phosphate - You voluntarily agree to participate **You may NOT be eligible if...** - You have already been taking Nephoxil - You have conditions that make participating unsafe, as determined by your doctor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGthe low-dose group (1.5 g/day) or the standard-dose group (4 g/day)

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)

Jesus Hospital

Jeonju, South Korea

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NCT06206135

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