Endoscopy in CKD With Iron Deficiency Anemia

January 3, 2024 updated by: Walid Ahmed Ragab Abdelhamid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients with chronic kidney disease.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

CKD patients stage (I-V)

Description

  • Patients with eGFR is less than 60 ml/m/1.73 m2.
  • Patients with iron deficiency anemia.
  • Absence of gastrointestinal symptoms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group 1
Chronic kidney diseases patients with iron deficiency anemia and eGFR ≥ 60 ml/min/1.73 m2
Procedure: Upper GIT endoscopy
Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions
Experimental: Group 2
Chronic kidney diseases patients with iron deficiency anemia and eGFR < 60 ml/min/1.73 m2.
Procedure: Upper GIT endoscopy
Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walid Ahmed Ragab Abdelhamid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

April 15, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9145/2-2-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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