Serum Hepcidin, Haemoglobin Level and Iron Status in Chro... | NCT04102319

Studies
Serum Hepcidin, Haemoglobin Level and Iron Status in Chronic Kidney Disease Patients (CKD) With Anaemia

NCT04102319

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Sep 25, 2019Actual

Enrollment

64Estimated

Phase

Not provided

Conditions

CKD Stage 4

Interventions

serum hepcidin

Countries

Not provided

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Estimated

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Sep 19, 2019

First Submission Date that Met QC Criteria

Sep 22, 2019

First Posted Date

Sep 25, 2019Actual

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

Sep 22, 2019

Last Update Posted Date

Sep 25, 2019Actual

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 current study is planned to assess possible relationships of serum hepcidin levels with haemoglobin levels, inflammation and iron statuses in stage 4 CKD patients.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Name	Type	Description	Arm Group Labels	Other Names
serum hepcidin	Diagnostic Test	it is a serum marker

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
relation between serum hepcidin level and ESR ckd stage 4	measure strength of relation, r, between levels of serum hepcidin and ESR, an inflammation marker	at study entry and then again after 3 months
relation between serum hepcidin and serum ferritin levels	measure strength of relation, r, between levels of hecidin and ferritin	at study entry and then again after 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (>18 years) with anaemia who had CKD stage 4 with glomerular filtration rate (GFR) 15-29 ml/min/1.73 m2

Exclusion Criteria:

Subjects with blood transfusion within the preceding 3 months. myocardial infarction (MI) history within the preceding 3 months, surgical history within the preceding 3 months, malignancy. Advanced liver cirrhosis. uncontrolled diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with chronic kidney disease stage 4 who have anemia with hemoglobin level below 11 gm/dl

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Deiaaeldeen Mohamed, master degree	Contact	+201032997001		deiaa_1981@yahoo.com

Overall Officials

Name	Affiliation	Role
Mohamed Hamed, MD	Assiut University	Principal Investigator

Locations

Not provided