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

Launched by KYOWA KIRIN KOREA CO., LTD. · Jan 4, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a medication called Nephoxil, which comes in capsule form, for treating high phosphate levels in patients with chronic kidney disease (CKD) who are on hemodialysis. High phosphate levels can be a common issue for these patients, and the trial aims to see how well Nephoxil works in real-life medical settings over 48 weeks.

To participate in this study, you need to be an adult aged 19 or older and currently undergoing hemodialysis for CKD. This will be your first time taking Nephoxil to help manage your phosphate levels. The study is open to all genders, and you will need to provide your consent to join. During the trial, participants will receive the Nephoxil capsules as part of their regular treatment, and the research team will monitor your health and any side effects. It’s important to know that certain patients may not be eligible, such as those requiring certain other medications or those deemed unsuitable by the study doctor.

Gender

ALL

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