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

Recruiting

• Conditions: Hyperphosphatemia

• Registration Number: NCT06186934
• Lead Sponsor: Kyowa Kirin Korea Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2023-12-17
• Study Start: 2023-12-21
• Study First Posted: 2024-01-02
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum phosphorus levels	8 weeks	Effectiveness evaluation is performed based on Serum phosphorus levels (mg/dL) before and after Nephoxil administration. We collect the most recent measurements prior to the initial administration, and measurements after at least four and eight weeks of administration of Nephoxil

Trial Locations

Locations (1)

Jesus Hospital; 🇰🇷 Jeonju, Korea, Republic of