ClinicalTrials.gg
RecruitingNCT06186934Updated Apr 29, 2024

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

An observational study in Hyperphosphatemia, sponsored by Kyowa Kirin Korea Co., Ltd.. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Kyowa Kirin Korea Co., Ltd. (part of Kyowa Kirin Co., Ltd.) · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Hyperphosphatemia

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03

In context

Hyperphosphatemia

173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.

This study's planned enrollment of 600 is above the median of 200 across 25 observational studies indexed under Hyperphosphatemia.

Browse Hyperphosphatemia studies →

Lead sponsor

Kyowa Kirin Korea Co., Ltd. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patients with to receive Nephoxil

    • Patients with to the active substance or to any of the
    • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
8 Weeks
Patient registry
Yes

Interventions

  • Drugthe standard-dose group (4 g/day)

    Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

06

What researchers measure

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

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06186934
Responsible party
Sponsor
First posted
Jan 2, 2024
Start date
Dec 21, 2023
Primary completion
Jan 30, 2026 (estimated)
Completion
Jan 30, 2026 (estimated)
Last update
Apr 29, 2024

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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