Clinical trial NCT04083664: NGAL and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital
Official title: Assessment of Neutrophil Gelatinase Associated Lipocalin (NGAL) and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD (Chronic Kidney Disease) Stage 5D
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Bseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Walaa Hosny Hosny, Doctrate
role: STUDY_CHAIR
affiliation: Assiut University
name: Alaa Soliman Alaa Soliman, Doctrate
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.