Diabetic Kidney DiseaseSAN-08961NCT05631119
Biorepository of Biospecimen Samples in Matched Healthy Control Participants and Participants Diagnosed With Diabetic Kidney Disease, Chronic Kidney Disease, or Type 2 Diabetes
An observational study of Diabetic Kidney Disease and Diabetes Type 2, run by Sanguine Biosciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Kidney Disease, Diabetes Type 2, Chronic Kidney Diseases
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 23 Aug 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- The participant is willing and able to provide written informed consent
- The participant is willing and able to provide appropriate photo identification
- Participants aged 18 to 85
- Participants have been diagnosed with diabetic kidney disease. Enrollment preference for participants with stage 3 kidney disease but is not inclusionary.
- The participant is willing and able to provide written informed consent
- The participant is willing and able to provide appropriate photo identification
Show all 13Show fewer
- Participants aged 18 to 85
- Participants have been diagnosed with chronic kidney disease.
- The participant is willing and able to provide written informed consent
- The participant is willing and able to provide appropriate photo identification
- Participants aged 18 to 85
- Participants have been diagnosed with type 2 diabetes.
- 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.
Who cannot join
- Participants who are pregnant or are nursing
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- 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
- Participants who are pregnant or are nursing
Show all 22Show fewer
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- 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
- Participants have been diagnosed with acute kidney disease or diabetic kidney disease
- Cohort 3: Type 2 Diabetes
- Participants who are pregnant or are nursing
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- 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
- 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).
- Participants who are pregnant or are nursing
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- 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
- Participants not considered in general good health
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanguine Biosciences, Inc.
Woburn, Massachusetts, 01801
About this study
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.
Read the 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.
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start15 Dec 2022
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sanguine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631119
- Sponsor's protocol ID
- SAN-08961
- Acronym
- SAN-08961
- Status last verified
- Oct 2023
- First submitted
- 15 Nov 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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/
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.
PubMed 26444893Strimbu K, Tavel JA. What are biomarkers? Curr Opin HIV AIDS. 2010 Nov;5(6):463-6. doi: 10.1097/COH.0b013e32833ed177.
PubMed 20978388Quezada 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.
PubMed 29382490Kreeger 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
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.
PubMed 32034066Olivier 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.
PubMed 31561483Krassowski 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.
PubMed 33362867Subramanian 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.
PubMed 32076369Khan 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.
PubMed 32175717Roy 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.
PubMed 34634970Garcia-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.
PubMed 34198818
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05631119
- Acronym / sponsor ID
- SAN-08961 / SAN-08961
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Novo Nordisk A/S
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- The participant is willing and able to provide written informed consent
- The participant is willing and able to provide appropriate photo identification
- Participants aged 18 to 85
- Participants have been diagnosed with diabetic kidney disease. Enrollment preference for participants with stage 3 kidney disease but is not inclusionary.
- The participant is willing and able to provide written informed consent
Key exclusion criteria (22 listed)
- Participants who are pregnant or are nursing
- Participants with a known history of HIV, hepatitis, or other infectious diseases
- Participants who have taken an investigational product in the last 30 days
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- BackgroundNational 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/
- Background: PubMed 26444893Siwek 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.
- Background: PubMed 20978388Strimbu K, Tavel JA. What are biomarkers? Curr Opin HIV AIDS. 2010 Nov;5(6):463-6. doi: 10.1097/COH.0b013e32833ed177.
- Background: PubMed 29382490Quezada 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.
- BackgroundKreeger 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
- Background: PubMed 32034066Chuah 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.
- Background: PubMed 31561483Olivier 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.
- Background: PubMed 33362867Krassowski 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.
- Background: PubMed 32076369Subramanian 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.
- Background: PubMed 32175717Khan 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.
- Background: PubMed 34634970Roy 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.
- Background: PubMed 34198818Garcia-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.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Kidney Disease
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease and Diabetes Type 2, run by Sanguine Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect biospecimen samples (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05631119, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.