NGAL and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital

September 10, 2019 updated by: Mohammed Hussein Mahmoud, Assiut University

Assessment of Neutrophil Gelatinase Associated Lipocalin (NGAL) and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital

To assess the pattern of NGAL and Hepicidin in relation to anemia in End Stage Renal Disease Patients on regular hemodialysis in Assiut University Hospital and study the relation between both NGAL and Hepicidin.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic kidney disease have a chronic inflammatory state, due to many factors e.g. enhancedincidence of infections, the uremic milieu, elevated levels of proinflammatory cytokines, frequent presence of widespread arteriosclerosis, etc. Iron metabolism is disturbedin chronic inflammatory diseases.AlteredNGAL levels in hemodialysis patients was probablydue to the fact that this protein was involved in ironmetabolism and suggested that NGAL might be anew tool in the assessment of iron deficiency.Another study found in multipleregression analysis that; residual renal function, hepcidin,creatinine and hsCRP were predictors of serum NGAL inhemodialyzed patients. They concluded that NGAL is highly induced in dialyzed patients and could reflect both kidney function and iron metabolism.Several studies suggested that hepcidin plays a role as anegative regulator of intestinal iron absorption and ironrelease from macrophages. Hepcidin controls intestinal ironabsorption by regulating ferroportin expression on thebasolateral membrane of enterocytes .Hepicidin is also an acute phase reactant.Both NGAL and hepcidin are elevated inchronic kidney disease,not only through ironmetabolism, but both are also associated with inflammationand may be related to anemia. Possible relationship between NGAL and hepicidin is still under study.

Study Type

Observational

Enrollment (Anticipated)

70

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

Study Contact Backup

  • Name: Mohammed Ali, Doctrate
  • Phone Number: +201227370775

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

End stage renal disease patients will be recruited from Assiut University Hemodialysis Unit, 30 patients in each group and 12 controls should be recruited.

Description

Inclusion Criteria:

For group 1:

  1. Adults > 18 years.
  2. Age and sex matched.
  3. No active infection or inflammation.

For group 2:

  1. Adults > 18 years.
  2. ESRD patients on regular hemodialysis.
  3. Hgb < 11g/dl.
  4. No apparent infection or inflammation.

For group 3:

  1. Adults > 18 years.
  2. ESRD patients on regular hemodialysis.
  3. Hgb ≥ 11g/dl.
  4. No apparent infection or inflammation.

Exclusion Criteria:

  1. Children and those >60 Years.
  2. Pregnant female.
  3. Patients with severe infection or with other immune system diseases.

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control healthy subjects without anemia.
  1. Adults > 18 years.
  2. Age and sex matched.
  3. No active infection or inflammation.
Diagnostic test: NGAL and Hepcidin
Both NGAL and hepcidin are elevated inchronic kidney disease,not only through iron metabolism, but both are also associated with inflammationand may be related to anemia
ESRD with Hgb <11 g/dl.
  1. Adults > 18 years.
  2. ESRD patients on regular hemodialysis.
  3. Hgb < 11g/dl.
  4. No apparent infection or inflammation.
Diagnostic test: NGAL and Hepcidin
Both NGAL and hepcidin are elevated inchronic kidney disease,not only through iron metabolism, but both are also associated with inflammationand may be related to anemia
ESRD with Hgb ≥ 11 g/dl
  1. Adults > 18 years.
  2. ESRD patients on regular hemodialysis.
  3. Hgb ≥ 11g/dl.
  4. No apparent infection or inflammation.
Diagnostic test: NGAL and Hepcidin
Both NGAL and hepcidin are elevated inchronic kidney disease,not only through iron metabolism, but both are also associated with inflammationand may be related to anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Neutrophil Gelatinase Associated Lipocalin (NGAL) and Hepcidin levels in Hemodialysis patients in Assiut University Hospital, 60 patients and 12 controls will be recruited.
Time Frame: Bseline
Assess the pattern of NGAL and Hepicidin in relation to anemia in End Stage Renal Disease Patients on regular hemodialysis in Assiut University Hospital and study the relation between both NGAL and Hepicidin.
Bseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: Walaa Hosny Hosny, Doctrate, Faculty of medicine - Assuit University
  • Principal Investigator: Alaa Soliman Alaa Soliman, Doctrate, Faculty of medicine - Assuit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 4, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

September 6, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGAL and Hepcidin in CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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