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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06186934

Enrollment

600

Registered

2024-01-02

Start date

2023-12-21

Completion date

2026-01-30

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperphosphatemia

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

Interventions

DRUGthe standard-dose group (4 g/day)

Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary Contacthyeokjun choi

hyeokjun.choi.2j@kyowakirin.com01074713471

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026