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

Astute Medical

Status: Enrolling

Conditions: Healthy; Chronic Disease

Treatments: Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Study type: Observational

Funder types: Industry

Identifiers

NCT05853016

AST-017

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Cohort A

Inclusion Criteria:

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

Exclusion Criteria:

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

Cohort B

Inclusion Criteria:

1. Adults (age > 21 years);
2. One or more of the following chronic, stable morbid conditions:

i. Active cancer ii. Arrhythmia (atrial fibrillation, heart block, ventricular tachycardia) iii. Chronic coagulation abnormality iv. Chronic obstructive pulmonary disease (including emphysema, chronic bronchitis, and asthma) v. Chronic pancreatitis vi. Chronic renal insufficiency vii. Congestive heart failure viii. Coronary artery disease ix. Diabetes mellitus (Type 1 or Type 2) x. Gout xi. Hyper- or hypothyroidism xii. Hyperlipidemia (includes hypercholesterolemia) xiii. Hypertension xiv. Immunocompromised xv. Inflammatory bowel disease (including Crohn's disease and ulcerative colitis) xvi. Liver cirrhosis xvii. Neuromuscular disease xviii. Peripheral vascular disease (a.k.a. peripheral artery disease) xix. Polycystic kidney disease xx. Rheumatoid arthritis xxi. Systemic Lupus Erythematosus c. Provide written informed consent for study participation.

Exclusion Criteria:

1. Any known or suspected acute illness or condition - including acute infections - at the time of enrollment or within the previous 30 days;
2. Any new onset or unstable morbidities;
3. Trauma-related surgery within the last 6 months;
4. Any surgery, hospitalization or institutionalization (such as in a nursing home) during the previous 3 months;
5. Received any blood product transfusion within the previous 2 months;
6. Pregnant women or children;
7. Prisoners or institutionalized individuals;
8. Already provided a urine sample for this study.

Trial design

600 participants in 2 patient groups

Cohort A

Description:

Healthy adults

Treatment:

Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test

Cohort B

Description:

Adults with stable chronic morbidities

Treatment:

Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test