Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102319
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Deiaaeldeen Masaoud Sadeq Mohammed, Assiut University

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.

Condition or disease Intervention/treatment
CKD Stage 4 Diagnostic Test: serum hepcidin

Layout table for study information
Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Association Between Hepcidin, Haemoglobin Level and Iron Status in Stage 4 Chronic Kidney Disease Patients With Anaemia
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: serum hepcidin
    it is a serum marker


Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102319


Contacts
Layout table for location contacts
Contact: Deiaaeldeen Mohamed, master degree +201032997001 deiaa_1981@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed Hamed, MD Assiut University

Layout table for additonal information
Responsible Party: Deiaaeldeen Masaoud Sadeq Mohammed, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT04102319    
Other Study ID Numbers: hepcidin,Anemia
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Hepcidins
Anti-Infective Agents