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

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

Study Overview

• Status: Recruiting
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: the standard-dose group (4 g/day)

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: hyeokjun choi; Phone Number: 01074713471; Email: hyeokjun.choi.2j@kyowakirin.com

Study Locations

• Korea, Republic of
  • Jeonju, Korea, Republic of
    • Recruiting
    • Jesus Hospital
    • Contact: Ayeong cho; Email: loveharuka@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum phosphorus levels	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	8 weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin Korea Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Estimated): January 30, 2026
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: Nephoxil PMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No