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

Healthy Clinical Trial

— SAN-08961  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631119
• Other study ID #: SAN-08961
• Status: Completed
• Start date: December 15, 2022
• Est. completion date: August 23, 2023

Study information

• Verified date: October 2023
• Source: Sanguine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Kidney Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Healthy
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	Sanguine Biosciences, Inc.	Woburn	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Sanguine Biosciences	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

References & Publications (12)

Chuah S, Chew V. High-dimensional immune-profiling in cancer: implications for immunotherapy. J Immunother Cancer. 2020 Feb;8(1):e000363. doi: 10.1136/jitc-2019-000363. — View Citation

Garcia-Carro C, Vergara A, Bermejo S, Azancot MA, Sanchez-Fructuoso AI, Sanchez de la Nieta MD, Agraz I, Soler MJ. How to Assess Diabetic Kidney Disease Progression? From Albuminuria to GFR. J Clin Med. 2021 Jun 5;10(11):2505. doi: 10.3390/jcm10112505. — View Citation

Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001. — View Citation

Krassowski M, Das V, Sahu SK, Misra BB. State of the Field in Multi-Omics Research: From Computational Needs to Data Mining and Sharing. Front Genet. 2020 Dec 10;11:610798. doi: 10.3389/fgene.2020.610798. eCollection 2020. — View Citation

Kreeger K. Immune Profiling: A New Opportunity for Drug Development. Penn Medicine News. February 14, 2019. Accessed: 20 October 2022. https://www.pennmedicine.org/news/news-blog/2019/february/immune-profiling-a-new-opportunity-for-drug-development

National Institute of Health (NIH): National Center for Advancing Translational Sciences. Understanding Translational Research Tools: Biorepository. Accessed: 19 October 2022. https://toolkit.ncats.nih.gov/module/discovery/developing-translational-research-tools/biorepository/

Olivier M, Asmis R, Hawkins GA, Howard TD, Cox LA. The Need for Multi-Omics Biomarker Signatures in Precision Medicine. Int J Mol Sci. 2019 Sep 26;20(19):4781. doi: 10.3390/ijms20194781. — View Citation

Quezada H, Guzman-Ortiz AL, Diaz-Sanchez H, Valle-Rios R, Aguirre-Hernandez J. Omics-based biomarkers: current status and potential use in the clinic. Bol Med Hosp Infant Mex. 2017 May-Jun;74(3):219-226. doi: 10.1016/j.bmhimx.2017.03.003. Epub 2017 May 10. — View Citation

Roy S, Schweiker-Kahn O, Jafry B, Masel-Miller R, Raju RS, O'Neill LMO, Correia CR, Trivedi A, Johnson C, Pilot C, Saddemi J, Memon A, Chen A, McHugh SP, Patel S, Daroshefski NM, Nguyen T, Wissler W, Sharma E, Hunter K. Risk Factors and Comorbidities Associated with Diabetic Kidney Disease. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211048556. doi: 10.1177/21501327211048556. — View Citation

Siwek M. An Overview of Biorepositories-Past, Present, and Future. Mil Med. 2015 Oct;180(10 Suppl):57-66. doi: 10.7205/MILMED-D-15-00119. — View Citation

Strimbu K, Tavel JA. What are biomarkers? Curr Opin HIV AIDS. 2010 Nov;5(6):463-6. doi: 10.1097/COH.0b013e32833ed177. — View Citation

Subramanian I, Verma S, Kumar S, Jere A, Anamika K. Multi-omics Data Integration, Interpretation, and Its Application. Bioinform Biol Insights. 2020 Jan 31;14:1177932219899051. doi: 10.1177/1177932219899051. eCollection 2020. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	collect biospecimen samples	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