- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04874753
The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease (COVID19-CKD)
May 2, 2021 updated by: Zelal Adibelli, Uşak University
COVID-19 pandemic affected the admission of patients to the hospital especially the older patients (> 65 years old) because of curfews and the reluctance of patients to apply to the hospitals.
Chronic kidney disease is characterized with the progressive loss of kidney function over the time and regular follow-up of patients for their kidney function and treatment of complications is recommended in these patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The chronis kidney disease patients followed in Nephrology outpatient unit are going to be enrolled in the study and their kidney functions (calculated with the mdrd formula to asses the estimated glomerular filtration rate (eGFR)) will be evaluated 6 months before and after the COVID-19 pandemia.
And the rate of initiation of renal replacement therapies and the change in proteinuria will be evaluated 6 months before and after the COVID-19 pandemic.
Study Type
Observational
Enrollment (Actual)
200
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
-
-
-
Usak, Turkey, 64100
- Uşak 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 to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with chronic kidney disease (eGFR<60 ml/dk) between the ages 18-80 followed up in nephrology outpatient clinic.
Description
Inclusion Criteria:
- patients with chronic kidney disease on regular follow-up for 6 months before the COVID19 pandemic.
Exclusion Criteria:
- patients without chronic kidney disease
- patients not on routine follow-up for 6 months before the COVID19 pandemic
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
eGFR change
Time Frame: 6 months
|
a rise or decrease in eGFR
|
6 months
|
|
change in proteinuria
Time Frame: 6 months
|
increase or decrease in ptoteinuria levels
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
initiation of renal replacement therapies
Time Frame: 6 months
|
need for hemodialysis or peritoneal dialysis
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zelal Adıbelli, Uşak University
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)
November 3, 2020
Primary Completion (ACTUAL)
December 1, 2020
Study Completion (ACTUAL)
January 1, 2021
Study Registration Dates
First Submitted
May 2, 2021
First Submitted That Met QC Criteria
May 2, 2021
First Posted (ACTUAL)
May 6, 2021
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2021
Last Update Submitted That Met QC Criteria
May 2, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Urologic Diseases
- Urological Manifestations
- Renal Insufficiency
- Urination Disorders
- COVID-19
- Kidney Diseases
- Renal Insufficiency, Chronic
- Proteinuria
Other Study ID Numbers
- UsakU4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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