NCT05240677

Brief Summary

Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

February 4, 2022

Last Update Submit

January 3, 2024

Conditions

Chronic Kidney DiseasesIron-Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (2)

Group 1

PLACEBO COMPARATOR

Chronic kidney diseases patients with iron deficiency anemia and eGFR ≥ 60 ml/min/1.73 m2

Procedure: Upper GIT endoscopy

Group 2

EXPERIMENTAL

Chronic kidney diseases patients with iron deficiency anemia and eGFR \< 60 ml/min/1.73 m2.

Procedure: Upper GIT endoscopy

Interventions

Upper GIT endoscopyPROCEDURE

Upper gastrointestinal endoscpy for all participants and gastric biopsy for histopathological examination for suspicious lesions

Group 1Group 2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Patients with eGFR is less than 60 ml/m/1.73 m2. * Patients with iron deficiency anemia. * Absence of gastrointestinal symptoms.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Zagazig university

Zagazig, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer internal medicine

Study Record Dates

First Submitted

February 4, 2022

First Posted

February 15, 2022

Study Start

May 1, 2021

Primary Completion

March 15, 2022

Study Completion

April 15, 2022

Last Updated

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)