CKD (Chronic Kidney Disease) Stage 5DNCT04083664
NGAL and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital
An observational study of CKD (Chronic Kidney Disease) Stage 5D, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- CKD (Chronic Kidney Disease) Stage 5D
- What is being tested?
- NGAL and Hepcidin
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2019to Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- For group 1:
- Adults > 18 years.
- Age and sex matched.
- No active infection or inflammation.
- For group 2:
- Adults > 18 years.
Show all 14Show fewer
- 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.
Who cannot join
- Children and those >60 Years.
- Pregnant female.
- Patients with severe infection or with other immune system diseases.
Trial locations and contacts
No sites are listed yet.
Mohammed Ali, Doctrate contact
About this study
Official title: 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.
Read the 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.
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D
- Being tested
- NGAL and Hepcidin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGAL and HepcidinDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Control healthy subjects without anemia. | 1. Adults > 18 years.
2. Age and sex matched.
3. No active infection or inflammation. Receives: 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. Receives: 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. Receives: Diagnostic Test: NGAL and Hepcidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Bseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start4 Sep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CKD (Chronic Kidney Disease) Stage 5DStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hussein Mahmoud, Assiut University
- Investigators
- Walaa Hosny Hosny, Doctrate, Study chair, Assiut UniversityAlaa Soliman Alaa Soliman, Doctrate, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083664
- Sponsor's protocol ID
- NGAL and Hepcidin in CKD
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 12 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26539647Emans 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.
PubMed 23235391Malyszko 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.
PubMed 20424477Malyszko 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.
PubMed 30818219
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Neutrophil Gelatinase Associated Lipocalin (NGAL) and Hepcidin Levels in Hemodialysis Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT04083664
- Acronym / sponsor ID
- NGAL and Hepcidin in CKD
- Conditions
- CKD (Chronic Kidney Disease) Stage 5D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 4 Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control healthy subjects without anemia. | – | Diagnostic Test: NGAL and Hepcidin1. Adults > 18 years. 2. Age and sex matched. 3. No active infection or inflammation. |
| ESRD with Hgb <11 g/dl. | – | Diagnostic Test: NGAL and Hepcidin1. Adults > 18 years. 2. ESRD patients on regular hemodialysis. 3. Hgb < 11g/dl. 4. No apparent infection or inflammation. |
| ESRD with Hgb ≥ 11 g/dl | – | Diagnostic Test: NGAL and Hepcidin1. Adults > 18 years. 2. ESRD patients on regular hemodialysis. 3. Hgb ≥ 11g/dl. 4. No apparent infection or inflammation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (14 listed)
- Adults > 18 years.
- Age and sex matched.
- No active infection or inflammation.
- Adults > 18 years.
- ESRD patients on regular hemodialysis.
Key exclusion criteria (3 listed)
- Children and those >60 Years.
- Pregnant female.
- Patients with severe infection or with other immune system diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGAL and HepcidinBoth 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 | Diagnostic test | Control healthy subjects without anemia., ESRD with Hgb <11 g/dl., ESRD with Hgb ≥ 11 g/dl |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Background: PubMed 26539647Yilmaz 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.
- Background: PubMed 23235391Emans 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.
- Background: PubMed 20424477Malyszko 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.
- Background: PubMed 30818219Malyszko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Ali, Doctrate contact
Walaa Hosny Hosny, Doctrate study chair
Assiut University
Alaa Soliman Alaa Soliman, Doctrate principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of CKD (Chronic Kidney Disease) Stage 5D, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Hussein, Master (+201005453884, drmohmedh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Bseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04083664, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.