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

NCT06186934 | Recruiting

• 1 other identifier: Nephoxil PMS
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

the standard-dose group (4 g/day) DRUG

Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

You may qualify if:

• Adults 19 years of age or older
• CKD patients undergoing hemodialysis to whom Nephoxil capsule administration is deemed necessary for improvement of hyperphosphatemia as per the determination of the investigator
• Patients who received Nephoxil capsule for the first time according to the national approval after conclusion of the contract with the study institution
• Those (or his / her legal guardian) who have agreed in writing to participate in the survey

You may not qualify if:

• 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)
• Patients who intend to use this drug for non-approved indications
• Patients who participated in pre-market clinical trials with Nephoxil
• Patients who took this drug before the starting day of this survey

Sponsors & Collaborators

• Kyowa Kirin Korea Co., Ltd.: lead

Study Sites (1)

Jesus Hospital

Jeonju, South Korea

RECRUITING

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

hyeokjun choi

CONTACT

01074713471; hyeokjun.choi.2j@kyowakirin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 2, 2024
• Study Start: December 21, 2023
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

KR (1)