Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes (SAN-08961)

Sanguine Biosciences

Status: Completed

Conditions: Chronic Kidney Diseases; Healthy; Diabetes Type 2; Diabetic Kidney Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05631119

SAN-08961

Details and patient eligibility

About

The Investigators will generate a repository of human biosamples across therapeutic areas that will be used to identify disease-associated biomarkers and potential targets with immune and multi-omics profiling. This sample collection and analysis from people living with type 2 diabetes, or chronic or diabetic kidney disease will lay the groundwork for an extensive network of biosample access and linked datasets that will provide an invaluable resource for translational research.

Full description

The Investigators will generate a repository of human biosamples across therapeutic areas that will be used to identify disease-associated biomarkers and potential targets with immune and multi-omics profiling. This sample collection and analysis from people living with type 2 diabetes, or chronic or diabetic kidney disease will lay the groundwork for an extensive network of biosample access and linked datasets that will provide an invaluable resource for translational research.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Cohort 1: Diabetic Kidney Disease

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 18 to 85
4. Participants have been diagnosed with diabetic kidney disease. Enrollment preference for participants with stage 3 kidney disease but is not inclusionary.

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months

Cohort 2: Chronic Kidney Disease

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 18 to 85
4. Participants have been diagnosed with chronic kidney disease.

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
5. Participants have been diagnosed with acute kidney disease or diabetic kidney disease

Cohort 3: Type 2 Diabetes

Inclusion:

1. The participant is willing and able to provide written informed consent
2. The participant is willing and able to provide appropriate photo identification
3. Participants aged 18 to 85
4. Participants have been diagnosed with type 2 diabetes.

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
5. Participants have been diagnosed with type 1 diabetes

Cohort 4: Healthy Matched The study will enroll participants considered healthy matched controls per the eligibility criteria. The healthy-matched controls must match each participant in the diseased cohorts by age (+/- 10 years).

Inclusion:

1. The participant is willing and able to provide written informed consent 2. The participant is willing and able to provide appropriate photo identification 3. Participants aged 18 to 85 4. Participants who are in generally good health are defined as: b. Participants may have a common/mild health condition(s) that are generally under control, including but not limited to: i. Hypertension, high cholesterol, asthma, anxiety, depression, attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBS), allergies, eczema, migraines, osteoarthritis, sleep apnea, restless leg syndrome, and eye issues (e.g., myopia, astigmatism, etc.) ii. Participants with a previous diagnosis and have recovered from COVID-19 iii. Participants in general good health may also take nonsteroidal anti-inflammatory drugs (NSAIDS) (i.e., ibuprofen, Tylenol, aspirin, Excedrin) irregularly or semi-regularly due to conditions like headache, body aches, cold/flu treatment as long as the medications are not being used for the treatment of a major underlying condition.

Exclusion:

1. Participants who are pregnant or are nursing
2. Participants with a known history of HIV, hepatitis, or other infectious diseases
3. Participants who have taken an investigational product in the last 30 days
4. Participants who have experienced excess blood loss, including blood donation, defined as 250 mL in the last month or 500 mL in the previous two months
5. Participants not considered in general good health

Trial design

40 participants in 4 patient groups

Diabetic Kidney Disease

Description:

Sample Collection: * Whole blood will be collected in 3 x 5 mL SST tubes. The samples will be centrifuged into 5 x 1 mL serum aliquots. The aliquots will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Whole blood will be collected in 4 x 10 mL and 1 x 4 mL sodium heparin tubes. The samples will be shipped ambient overnight to Sanguine Labs via FedEx Priority Overnight by 10:30 am. Sanguine Labs will process the samples for PBMC isolations at 10 million cells per aliquot. Samples will be stored for batch shipment at the end of the study. The PBMC aliquot(s) will be shipped overnight using liquid nitrogen (LN2) to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Urine will be collected using a Vacuette collection device. The sample will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30

Chronic Kidney Disease

Description:

Sample Collection: * Whole blood will be collected in 3 x 5 mL SST tubes. The samples will be centrifuged into 5 x 1 mL serum aliquots. The aliquots will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Whole blood will be collected in 4 x 10 mL and 1 x 4 mL sodium heparin tubes. The samples will be shipped ambient overnight to Sanguine Labs via FedEx Priority Overnight by 10:30 am. Sanguine Labs will process the samples for PBMC isolations at 10 million cells per aliquot. Samples will be stored for batch shipment at the end of the study. The PBMC aliquot(s) will be shipped overnight using liquid nitrogen (LN2) to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Urine will be collected using a Vacuette collection device. The sample will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am

Type 2 Diabetes

Description:

Sample Collection: * Whole blood will be collected in 3 x 5 mL SST tubes. The samples will be centrifuged into 5 x 1 mL serum aliquots. The aliquots will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Whole blood will be collected in 8 x 10 mL and 1 x 4 mL sodium heparin tubes. The samples will be shipped ambient overnight to Sanguine Labs via FedEx Priority Overnight by 10:30 am. Sanguine Labs will process the samples for PBMC isolations at 10 mL cells per aliquot. Samples will be stored for batch shipment at the end of the study. The PBMC aliquot(s) will be shipped overnight using liquid nitrogen (LN2) to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Urine will be collected using a Vacuette collection device. The sample will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am.

Healthy Matched Controls

Description:

Sample Collection: * Whole blood will be collected in 3 x 5 mL SST tubes. The samples will be centrifuged into 5 x 1 mL serum aliquots. The aliquots will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Whole blood will be collected in 16 x 10 mL and 1 x 4 mL sodium heparin tubes. The samples will be shipped ambient overnight to Sanguine Labs via FedEx Priority Overnight by 10:30 am. Sanguine Labs will process the samples for PBMC isolations at 10 mL cells per aliquot. Samples will be stored for batch shipment at the end of the study. The PBMC aliquot(s) will be shipped overnight using liquid nitrogen (LN2) to Novo Nordisk via FedEx Priority Overnight by 10:30 am. * Urine will be collected using a Vacuette collection device. The sample will be shipped frozen (with dry ice) overnight to Novo Nordisk via FedEx Priority Overnight by 10:30 am.