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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05631119
Acronym
SAN-08961
Enrollment
40
Registered
2022-11-30
Start date
2022-12-15
Completion date
2023-08-23
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Diabetes Type 2, Diabetic Kidney Disease, Healthy

Brief summary

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.

Detailed 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.

Interventions

None listed

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Sanguine Biosciences
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
collect biospecimen samples7 monthsThe study objective is to collect biospecimen samples (e.g., blood and urine) from participants diagnosed with diabetic kidney disease, chronic kidney disease, or type 2 diabetes. These samples will be used to 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026