A Urine Sample Collection Study in Apparently Healthy Adults and Adults With Chronic, Stable Morbidities

Astute Medical, Inc.1 site in 1 country600 target enrollmentMarch 21, 2022

ConditionsHealthy Chronic Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Astute Medical, Inc.
Enrollment: 600
Locations: 1
Primary Endpoint: Reference interval as defined by Clinical and Laboratory Standards Institute guideline EP28 for urinary C-C motif chemokine 14 concentration measured with the NEPHROCLEAR CCL14 Test within each cohort
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is collect urine samples from healthy adult subjects and subjects with stable chronic morbidities for future testing to serve as controls and establish reference ranges in the development of new invitro diagnostic devices.

Registry

clinicaltrials.gov

Start Date

March 21, 2022

End Date

May 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Astute Medical, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Apparently healthy adults (age \> 21 years);
•Provide written informed consent for study participation.

Exclusion Criteria

•Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
•Any known or suspected significant new onset or chronic morbid medical condition such as those listed in the inclusion criteria for Cohort B;
•Trauma-related surgery within the last 6 months;
•Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
•Received any blood product transfusion within the previous 2 months;
•Pregnant women or children;
•Prisoners or institutionalized individuals;
•Already provided a urine sample for this study.
•Inclusion Criteria:
•Adults (age \> 21 years);

Outcomes

Primary Outcomes

Reference interval as defined by Clinical and Laboratory Standards Institute guideline EP28 for urinary C-C motif chemokine 14 concentration measured with the NEPHROCLEAR CCL14 Test within each cohort

Time Frame: Determined for urine sample collected at baseline