NGAL and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital

NCT04083664 | Unknown

• 1 other identifier: NGAL and Hepcidin in CKD
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CKD (Chronic Kidney Disease) Stage 5D

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (3)

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

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

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

Interventions

NGAL and Hepcidin 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

Control healthy subjects without anemia.; ESRD with Hgb <11 g/dl.; ESRD with Hgb ≥ 11 g/dl

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• For group 1:
• Adults \> 18 years.
• Age and sex matched.
• No active infection or inflammation.
• For group 2:
• Adults \> 18 years.
• ESRD patients on regular hemodialysis.
• Hgb \< 11g/dl.
• No apparent infection or inflammation.
• For group 3:
• Adults \> 18 years.
• ESRD patients on regular hemodialysis.
• Hgb ≥ 11g/dl.
• No apparent infection or inflammation.

You may not qualify if:

• Children and those \>60 Years.
• Pregnant female.
• Patients with severe infection or with other immune system diseases.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 26539647 BACKGROUND

• 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.

  PMID: 23235391 BACKGROUND

• 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.

  PMID: 20424477 BACKGROUND

• 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.

  PMID: 30818219 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walaa Hosny Hosny, Doctrate

  Assiut University

  STUDY CHAIR

• Alaa Soliman Alaa Soliman, Doctrate

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Hussein, Master

CONTACT

+201005453884; drmohmedh@gmail.com

Mohammed Ali, Doctrate

CONTACT

+201227370775

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: September 4, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 12, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share