Kidney Disease After COVID-19

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT05328986

Collaborator

New Jersey Medical School (Other), University of Michigan (Other), Yale New Haven Health System Center for Healthcare Solutions (Other), Johns Hopkins University (Other)

3,000

Enrollment

Locations

Anticipated Duration (Months)

600

Patients Per Site

12.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To understand the long-term epidemiology, develop effective risk-prediction and stratification tools, and understand the pathobiology of kidney disease in COVID-19 survivors.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Kidney Injury Chronic Kidney Injury

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multi-center Assessment of Survivors for Kidney Disease After COVID-19

Actual Study Start Date :

Jan 4, 2020

Anticipated Primary Completion Date :

Jan 4, 2024

Anticipated Study Completion Date :

Jan 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
COVID Patients who have had a confirmed diagnosis of COVID-19.

Outcome Measures

Primary Outcome Measures

estimated Glomerular Filtration Rate (eGFR) [yearly for 4 years after COVID exposure]
Kidneys filter blood by removing waste and extra water to make urine. The kidney's filtration rate, called the glomerular filtration rate (GFR), shows how well the kidneys are filtering. A normal GFR is 60 or higher.

Secondary Outcome Measures

Urine Albumin-to-Creatinine Ratio (UACR) [yearly for 4 years after COVID exposure]
Albuminuria is present when UACR is greater than 30 mg/g and is a marker for chronic kidney disease. Albuminuria is used to diagnose and monitor kidney disease.
Urine protein/creatinine ratio (UPCR) [yearly for 4 years after COVID exposure]
Urine protein/creatinine ratio - Protein creatinine ratio in the urine quantifies the loss of the protein and helps in further evaluation of the kidney function. Normal ratio: < 0.20

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria:

Inclusion Criteria:

Adults, age ≥18 years
Confirmed diagnosis of COVID-19

Exclusion Criteria:

• No confirmed diagnosis of COVID-19

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06513
2	Johns Hopkins University	Baltimore	Maryland	United States	21287
3	University of Michigan	Ann Arbor	Michigan	United States	48105
4	New Jersey Medical School - Rutgers University	Newark	New Jersey	United States	07103
5	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
New Jersey Medical School
University of Michigan
Yale New Haven Health System Center for Healthcare Solutions
Johns Hopkins University

Investigators

Principal Investigator: Evren U. Azeloglu, PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Evren Azeloglu, Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai

ClinicalTrials.gov Identifier:

NCT05328986

Other Study ID Numbers:

STUDY-20-01326
1300143

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 3, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022