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

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

Recruiting
19 years and older
All
Phase N/A

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Overview

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

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 details
    Hyperphosphatemia

NCT06186934

Kyowa Kirin Korea Co., Ltd.

15 May 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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