NGAL and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04083664
Collaborator
(none)
70
12.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: NGAL and Hepcidin

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 Design

Study Type:
Observational
Anticipated Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Assessment of Neutrophil Gelatinase Associated Lipocalin (NGAL) and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital
Anticipated Study Start Date :
Sep 4, 2019
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Control healthy subjects without anemia.

Adults > 18 years. Age and sex matched. 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.

Adults > 18 years. ESRD patients on regular hemodialysis. Hgb < 11g/dl. 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

Adults > 18 years. ESRD patients on regular hemodialysis. Hgb ≥ 11g/dl. 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

Outcome Measures

Primary Outcome Measures

  1. 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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohammed Hussein Mahmoud, Specialist, Assiut University
ClinicalTrials.gov Identifier:
NCT04083664
Other Study ID Numbers:
  • NGAL and Hepcidin in CKD
First Posted:
Sep 10, 2019
Last Update Posted:
Sep 12, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 12, 2019