Post Marketing Surveillance Study to Observe Safety and E... | NCT06186934

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

NCT06186934

Sponsor

Kyowa Kirin Korea Co., Ltd.

Status

Unknown status

Last Update Posted

Apr 29, 2024Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Hyperphosphatemia

Interventions

the standard-dose group (4 g/day)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2023Actual

Primary Completion Date

Jan 30, 2026Estimated

Completion Date

Jan 30, 2026Estimated

First Submitted Date

Dec 17, 2023

First Submission Date that Met QC Criteria

Dec 17, 2023

First Posted Date

Jan 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2024

Last Update Posted Date

Apr 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

8 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Name	Type	Description	Arm Group Labels	Other Names
the standard-dose group (4 g/day)	Drug	Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic kidney disease undergoing hemodialysis and controlling hyperphosphatemia

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
hyeokjun choi	Contact	01074713471		hyeokjun.choi.2j@kyowakirin.com

Facility	Status	City	State	ZIP	Country	Contacts
Jesus Hospital	Recruiting	Jeonju			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D003710	Demography
D011154	Population Characteristics