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

September 22, 2019 updated by: Deiaaeldeen Masaoud Sadeq Mohammed, Assiut University

Association Between Hepcidin, Haemoglobin Level and Iron Status in Stage 4 Chronic Kidney Disease Patients With Anaemia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mohamed Hamed, MD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2019

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 19, 2019

First Submitted That Met QC Criteria

September 22, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 22, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • hepcidin,Anemia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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