Chronic Kidney DiseasesNCT05240677
Endoscopy in CKD With Iron Deficiency Anemia
A study testing Upper GIT endoscopy in people with Chronic Kidney Diseases and Iron-Deficiency Anemia, run by Walid Ahmed Ragab Abdelhamid at 1 site in Egypt.
Trial summary
Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Iron-Deficiency Anemia
- What is being tested?
- Upper GIT endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 15 Apr 2022
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Patients with eGFR is less than 60 ml/m/1.73 m2.
- Patients with iron deficiency anemia.
- Absence of gastrointestinal symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of Esophageogastroduodenscopy in Assessment of Chronic Kidney Disease Patients With Iron Deficiency Anemia Without Gastrointestinal Symptoms
Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient.
Read the detailed description
Iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients with chronic kidney disease.
- Conditions
- Chronic Kidney Diseases, Iron-Deficiency Anemia
- Being tested
- Upper GIT endoscopy
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper GIT endoscopyProcedure or surgery
Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Chronic kidney diseases patients with iron deficiency anemia and eGFR ≥ 60 ml/min/1.73 m2 Receives: Procedure: Upper GIT endoscopy |
| Group 2 | Experimental | Chronic kidney diseases patients with iron deficiency anemia and eGFR < 60 ml/min/1.73 m2. Receives: Procedure: Upper GIT endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of upper gastrointestinal endoscopic findings In chronic kidney disease patients with iron deficiency anemia
Detect rate of upper GIT lesions in asymptomatic CKD patients with iron deficiency anemia using endoscopy followed by biopsy and histopathological examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start1 May 2021
- Primary completion15 Mar 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walid Ahmed Ragab Abdelhamid
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Walid Ahmed Ragab Abdelhamid, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240677
- Sponsor's protocol ID
- 9145/2-2-2022
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Esophageogastroduodenscopy in Assessment of Chronic Kidney Disease Patients With Iron Deficiency Anemia Without Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT05240677
- Acronym / sponsor ID
- 9145/2-2-2022
- Conditions
- Chronic Kidney Diseases, Iron-Deficiency Anemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Walid Ahmed Ragab AbdelhamidOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 15 Feb 2022 (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.
Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient.
Detailed description
Iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients with chronic kidney disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Procedure: Upper GIT endoscopyChronic kidney diseases patients with iron deficiency anemia and eGFR ≥ 60 ml/min/1.73 m2 |
| Group 2 | Experimental | Procedure: Upper GIT endoscopyChronic kidney diseases patients with iron deficiency anemia and eGFR < 60 ml/min/1.73 m2. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Upper GIT endoscopyUpper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Rate of upper gastrointestinal endoscopic findings In chronic kidney disease patients with iron deficiency anemia
Time frame: 6 months
Detect rate of upper GIT lesions in asymptomatic CKD patients with iron deficiency anemia using endoscopy followed by biopsy and histopathological examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper GIT endoscopy in people with Chronic Kidney Diseases and Iron-Deficiency Anemia, run by Walid Ahmed Ragab Abdelhamid at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of upper gastrointestinal endoscopic findings In chronic kidney disease patients with iron deficiency anemia (time frame: 6 months). 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 5 Jan 2024.