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)

October 2, 2023 updated by: Sanguine Biosciences
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Woburn, Massachusetts, United States, 01801
        • Sanguine Biosciences, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Diabetic Kidney Disease, Chronic Kidney Disease, and Diabetes Type 2. The 4th cohort will be a healthy match cohort of patients: 2 of the disease cohorts will have 3 healthy matched patieints and the final disease cohort (unspecified) will have 4 healthy patients matched.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diabetic Kidney Disease

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

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

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
collect biospecimen samples
Time Frame: 7 months
The 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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanguine Biosciences

Collaborators

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2022

Primary Completion (Actual)

August 23, 2023

Study Completion (Actual)

August 23, 2023

Study Registration Dates

First Submitted

November 15, 2022

First Submitted That Met QC Criteria

November 23, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAN-08961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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