Kidney Disease After COVID-19 | NCT05328986

Studies
Kidney Disease After COVID-19

NCT05328986

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Jul 20, 2025Actual

Enrollment

1,753Actual

Phase

Not provided

Conditions

COVID-19
Acute Kidney Injury
Chronic Kidney Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1300143	Other Identifier	Renalytix AI, Inc.

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 4, 2020Actual

Primary Completion Date

Jan 4, 2024Actual

Completion Date

Jan 4, 2024Actual

First Submitted Date

Apr 13, 2022

First Submission Date that Met QC Criteria

Apr 13, 2022

First Posted Date

Apr 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2025

Last Update Posted Date

Jul 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Evren Azeloglu, Associate Professor of Medicine, Icahn School of Medicine at Mount SinaiPrincipal Investigator

Lead Sponsor

Icahn School of Medicine at Mount SinaiOTHER

Collaborators

Name	Class
New Jersey Medical School	OTHER
University of Michigan	OTHER
Yale New Haven Health System Center for Healthcare Solutions	OTHER
Johns Hopkins University

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,753Actual

Label	Type	Description	Intervention Names
COVID		Patients who have had a confirmed diagnosis of COVID-19.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
estimated Glomerular Filtration Rate (eGFR)	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.	yearly for 4 years after COVID exposure

Secondary Outcomes

Measure	Description	Time Frame
Urine Albumin-to-Creatinine Ratio (UACR)	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.	yearly for 4 years after COVID exposure
Urine protein/creatinine ratio (UPCR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

• No confirmed diagnosis of COVID-19

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with COVID-19.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evren U. Azeloglu, PhD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale School of Medicine		New Haven	Connecticut	06513	United States
Johns Hopkins University

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All of the individual participant data collected during the trial, after deidentification.

Types

Study Protocol
Clinical Study Report (CSR)

Time Frame

Specify Other Time FrameData from this study may be requested from other researchers one year after the completion of the primary endpoint by contacting Dr. Evren Azeloglu.

Access Criteria

Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism

Any research team who utilizes the data must propose a research question (independent and dependent variable) and post their plan for analysis on a COVID-19 database that is available.
All teams need to abide by the requirement that data is analyzed within protected networks and that no data are downloaded or copied.
Any data sharing will only occur with the approval with each site PI and only with appropriate regulatory approvals.

Data will be deidentified.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

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Browse Branches

Not provided