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NCT06186934 Clinical Trial

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

Hyperphosphatemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06186934
Other study ID # Nephoxil PMS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2023
Est. completion date January 30, 2026

Study information
Verified date April 2024
Source Kyowa Kirin Co., Ltd.
Contact hyeokjun choi
Phone 01074713471
Email hyeokjun.choi.2j@kyowakirin.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 600
Est. completion date January 30, 2026
Est. primary completion date January 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• the standard-dose group (4 g/day)
Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Locations
Country Name City State
Korea, Republic of Jesus Hospital Jeonju

Sponsors (1)
Lead Sponsor Collaborator
Kyowa Kirin Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT01191255 - A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis Phase 3
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Completed NCT04551300 - A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients Phase 2
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Completed NCT00542815 - A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia Phase 3
Completed NCT04549597 - Study to Evaluate the Use of Tenapanor as Core Therapy in the Treatment of Hyperphosphatemia Phase 4