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

Kyowa Kirin

Status: Enrolling

Conditions: Hyperphosphatemia

Treatments: Drug: the standard-dose group (4 g/day)

Study type: Observational

Funder types: Industry

Identifiers

NCT06186934

Nephoxil PMS

Details and patient eligibility

About

The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of Nephoxil capsule 500 mg (Ferric Citrate 500 mg, equivalent to 105 mg Ferric Iron) in routine clinical settings

Enrollment: 600 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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