Post Marketing Surveillance Study to Observe Safety and Effectiveness of NEPHOXIL ® in S. Korea Patients

Launched by KYOWA KIRIN KOREA CO., LTD. · Dec 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Nephoxil, which is used to help manage high levels of phosphate in the blood, a condition known as hyperphosphatemia. The trial is specifically looking at patients in South Korea who have chronic kidney disease (CKD) and are undergoing a treatment called hemodialysis. If you are an adult aged 19 or older and have not previously used Nephoxil, you may be eligible to participate in this study.

Participants in the trial will take Nephoxil for the first time and will be monitored by healthcare professionals to see how well the medication works and if there are any side effects. To join, you would need to agree to participate in the study, and it’s important to note that certain individuals, such as those with specific allergies to the medication or other health conditions related to iron levels, may not be eligible. This trial aims to gather important information that can help improve treatment options for patients with high phosphate levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults 19 years of age or older
• • 2. CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
• • 3. Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
• • 4. Those (or his / her legal guardian) who have agreed in writing to participate in the survey
• Exclusion Criteria:
• • 1. 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)
• • 2. Patients who intend to use this drug for non-approved indications
• • 3. Patients who participated in pre-market clinical trials with Nephoxil
• • 4. Patients who took this drug before the starting day of this survey