CKD Stage 4NCT04102319
Serum Hepcidin, Haemoglobin Level and Iron Status in Chronic Kidney Disease Patients (CKD) With Anaemia
An observational study of CKD Stage 4, run by Assiut University.
Trial summary
The current study is planned to assess possible relationships of serum hepcidin levels with haemoglobin levels, inflammation and iron statuses in stage 4 CKD patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CKD Stage 4
- What is being tested?
- serum hepcidin
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with chronic kidney disease stage 4 who have anemia with hemoglobin level below 11 gm/dl
Who may be able to join
- Adult patients (>18 years) with anaemia who had CKD stage 4 with glomerular filtration rate (GFR) 15-29 ml/min/1.73 m2
Who cannot join
- Subjects with blood transfusion within the preceding 3 months. myocardial infarction (MI) history within the preceding 3 months, surgical history within the preceding 3 months, malignancy. Advanced liver cirrhosis. uncontrolled diabetes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association Between Hepcidin, Haemoglobin Level and Iron Status in Stage 4 Chronic Kidney Disease Patients With Anaemia
The current study is planned to assess possible relationships of serum hepcidin levels with haemoglobin levels, inflammation and iron statuses in stage 4 CKD patients.
- Conditions
- CKD Stage 4
- Being tested
- serum hepcidin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum hepcidinDiagnostic test
it is a serum marker
What is being measured
The primary outcome is the main question the study is designed to answer.
relation between serum hepcidin level and ESR ckd stage 4
measure strength of relation, r, between levels of serum hepcidin and ESR, an inflammation marker
Measured: at study entry and then again after 3 months
relation between serum hepcidin and serum ferritin levels
measure strength of relation, r, between levels of hecidin and ferritin
Measured: at study entry and then again after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD Stage 4Studies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deiaaeldeen Masaoud Sadeq Mohammed, Assiut University
- Investigators
- Mohamed Hamed, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102319
- Sponsor's protocol ID
- hepcidin,Anemia
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Hepcidin, Haemoglobin Level and Iron Status in Stage 4 Chronic Kidney Disease Patients With Anaemia
- ClinicalTrials.gov ID
- NCT04102319
- Acronym / sponsor ID
- hepcidin,Anemia
- Conditions
- CKD Stage 4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 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.
The current study is planned to assess possible relationships of serum hepcidin levels with haemoglobin levels, inflammation and iron statuses in stage 4 CKD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic kidney disease stage 4 who have anemia with hemoglobin level below 11 gm/dl
Key inclusion criteria (1 listed)
- Adult patients (>18 years) with anaemia who had CKD stage 4 with glomerular filtration rate (GFR) 15-29 ml/min/1.73 m2
Key exclusion criteria (1 listed)
- Subjects with blood transfusion within the preceding 3 months. myocardial infarction (MI) history within the preceding 3 months, surgical history within the preceding 3 months, malignancy. Advanced liver cirrhosis. uncontrolled diabetes
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 |
|---|---|---|
| serum hepcidinit is a serum marker | Diagnostic test | – |
Primary outcome
relation between serum hepcidin level and ESR ckd stage 4
Time frame: at study entry and then again after 3 months
measure strength of relation, r, between levels of serum hepcidin and ESR, an inflammation marker
relation between serum hepcidin and serum ferritin levels
Time frame: at study entry and then again after 3 months
measure strength of relation, r, between levels of hecidin and ferritin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
Related trials for CKD Stage 4
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Effect of Synbiotic Therapy on Renal Function Outcomes in Patients With Chronic Kidney Disease Stage III-IV: A Double-blind Randomized Placebo-controlled Trial.
Chronic Kidney Disease (Stage 3-4)
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
RecruitingObservational study
Feasibility of Estimating the Prevalence and Management of Stage 4 CKD the Gard, France
Renal Insufficiency, Chronic
RecruitingObservational study
Hyperlipoproteinemia A as a Marker of Cardiovascular Risk in Patients With Stage 4 Chronic Kidney Disease
CKD, Cardiovascular Diseases
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.
Mohamed Hamed, MD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of CKD Stage 4, 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 1 inclusion and 1 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 25 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 Deiaaeldeen Mohamed, master degree (+201032997001, deiaa_1981@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation between serum hepcidin level and ESR ckd stage 4 (time frame: at study entry and then again after 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2019.