- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102319
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
- Name: Deiaaeldeen Mohamed, master degree
- Phone Number: +201032997001
- Email: deiaa_1981@yahoo.com
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.
Sponsor
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
Additional Relevant MeSH Terms
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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