NGAL and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital

NCT ID: NCT04083664

Last Updated: 2019-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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CKD (Chronic Kidney Disease) Stage 5D

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control healthy subjects without anemia.

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

NGAL and Hepcidin

Intervention Type DIAGNOSTIC_TEST

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.

NGAL and Hepcidin

Intervention Type DIAGNOSTIC_TEST

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.

NGAL and Hepcidin

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hussein Mahmoud

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Hosny Hosny, Doctrate

Role: STUDY_CHAIR

Assiut University

Alaa Soliman Alaa Soliman, Doctrate

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Mohammed Hussein, Master

Role: CONTACT

+201005453884

Mohammed Ali, Doctrate

Role: CONTACT

+201227370775

References

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Yilmaz I, Ozkok A, Kostek O, Kolukisa A, Duran I, Odabas AR, Kemal Isman F, Isbilen Basok B. C-reactive protein but not hepcidin, NGAL and transferrin determines the ESA resistance in hemodialysis patients. Ren Fail. 2016;38(1):89-95. doi: 10.3109/0886022X.2015.1106896. Epub 2015 Nov 5.

Reference Type BACKGROUND
PMID: 26539647 (View on PubMed)

Emans ME, Braam B, Diepenbroek A, van der Putten K, Cramer MJ, Wielders JP, Swinkels DW, Doevendans PA, Gaillard CA. Neutrophil gelatinase-associated lipocalin (NGAL) in chronic cardiorenal failure is correlated with endogenous erythropoietin levels and decreases in response to low-dose erythropoietin treatment. Kidney Blood Press Res. 2012;36(1):344-54. doi: 10.1159/000343392. Epub 2012 Dec 12.

Reference Type BACKGROUND
PMID: 23235391 (View on PubMed)

Malyszko J, Malyszko JS, Kozminski P, Koc-Zorawska E, Mysliwiec M, Macdougall I. Possible relationship between neutrophil gelatinase-associated lipocalin, hepcidin, and inflammation in haemodialysed patients. Nephron Clin Pract. 2010;115(4):c268-75. doi: 10.1159/000313485. Epub 2010 Apr 28.

Reference Type BACKGROUND
PMID: 20424477 (View on PubMed)

Malyszko J, Bachorzewska-Gajewska H, Malyszko JS, Koc-Zorawska E, Matuszkiewicz-Rowinska J, Dobrzycki S. Hepcidin - Potential biomarker of contrast-induced acute kidney injury in patients undergoing percutaneous coronary interventions. Adv Med Sci. 2019 Sep;64(2):211-215. doi: 10.1016/j.advms.2018.12.008. Epub 2019 Feb 26.

Reference Type BACKGROUND
PMID: 30818219 (View on PubMed)

Other Identifiers

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NGAL and Hepcidin in CKD

Identifier Type: -

Identifier Source: org_study_id

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