Covid19COVID19-CKDNCT04874753
The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease
An observational study of Covid19 and Chronic Kidney Diseases, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19, Chronic Kidney Diseases, Proteinuria
- What is being tested?
- change in kidney function and proteinuria
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2020to 1 Jan 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic kidney disease (eGFR<60 ml/dk) between the ages 18-80 followed up in nephrology outpatient clinic.
Who may be able to join
- patients with chronic kidney disease on regular follow-up for 6 months before the COVID19 pandemic.
Who cannot join
- patients without chronic kidney disease
- patients not on routine follow-up for 6 months before the COVID19 pandemic
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Covid19, Chronic Kidney Diseases, Proteinuria
- Being tested
- change in kidney function and proteinuria
- Medical subject headings
- COVID-19, Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change in kidney function and proteinuriaOther
change in eGFR nad proteinuria in patients with chronic kidney disease
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR change
a rise or decrease in eGFR
Measured: 6 months
change in proteinuria
increase or decrease in ptoteinuria levels
Measured: 6 months
Secondary outcomes (1)
initiation of renal replacement therapies
need for hemodialysis or peritoneal dialysis
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 posted6 May 2021
- Study start3 Nov 2020
- Primary completion1 Dec 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zelal Adibelli, Uşak University
- Investigators
- Zelal Adıbelli, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874753
- Sponsor's protocol ID
- UsakU4
- Acronym
- COVID19-CKD
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04874753
- Acronym / sponsor ID
- COVID19-CKD / UsakU4
- Conditions
- Covid19, Chronic Kidney Diseases, Proteinuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 6 May 2021 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic kidney disease (eGFR<60 ml/dk) between the ages 18-80 followed up in nephrology outpatient clinic.
Key inclusion criteria (1 listed)
- patients with chronic kidney disease on regular follow-up for 6 months before the COVID19 pandemic.
Key exclusion criteria (2 listed)
- patients without chronic kidney disease
- patients not on routine follow-up for 6 months before the COVID19 pandemic
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 |
|---|---|---|
| change in kidney function and proteinuriachange in eGFR nad proteinuria in patients with chronic kidney disease | Other | – |
Primary outcome
eGFR change
Time frame: 6 months
a rise or decrease in eGFR
change in proteinuria
Time frame: 6 months
increase or decrease in ptoteinuria levels
1 secondary outcome
initiation of renal replacement therapies
Time frame: 6 months
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 6 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zelal Adıbelli principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Chronic Kidney Diseases, run by Uşak University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 6 May 2021. 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 Turkey (Türkiye). 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. 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?
eGFR change (time frame: 6 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 6 May 2021.