NCT04102319

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 25, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3 years

First QC Date

September 19, 2019

Last Update Submit

September 22, 2019

Conditions

CKD Stage 4

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

serum hepcidinDIAGNOSTIC_TEST

it is a serum marker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Mohamed Hamed, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deiaaeldeen Mohamed, master degree

CONTACT

+201032997001deiaa_1981@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 25, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2022

Study Completion

December 1, 2023

Last Updated

September 25, 2019

Record last verified: 2019-09