COVID19-CKD: The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease

• Sponsor: Uşak University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04874753
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 103.2

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Chronic Kidney Diseases; Proteinuria	Other: change in kidney function and proteinuria

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

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease
• Actual Study Start Date: Nov 3, 2020
• Actual Primary Completion Date: Dec 1, 2020
• Actual Study Completion Date: Jan 1, 2021

Outcome Measures

Primary Outcome Measures

1. eGFR change [6 months]

   a rise or decrease in eGFR

2. change in proteinuria [6 months]

   increase or decrease in ptoteinuria levels

Secondary Outcome Measures

1. initiation of renal replacement therapies [6 months]

   need for hemodialysis or peritoneal dialysis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Usak University	Usak		Turkey	64100

Sponsors and Collaborators

• Uşak University

Investigators

• Principal Investigator: Zelal Adıbelli, Uşak University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zelal Adibelli, Assistant Prof. Zelal Adibelli, Uşak University
• ClinicalTrials.gov Identifier: NCT04874753
• Other Study ID Numbers: UsakU4
• First Posted: May 6, 2021
• Last Update Posted: May 6, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria

Study Results

No Results Posted as of May 6, 2021