Diabetic Kidney DiseasePhase 4NCT07155694
Role of Finerenone in African American Veterans With Diabetic Kidney Disease
A Phase 4 study testing Finerenone 10 MG and Empagliflozin 10 MG in people with Diabetic Kidney Disease, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Finerenone 10 MG and Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random/ post prandial blood glucose of more than 199mg%)
- African American veterans
- Age 20-90 years
- eGFR ≥25-89 mL/min/1.73 m2 by the CKD-EPI equation)
- Albuminuria of 30 mg/g or higher
- BMI=18-39.9
- Blood pressure controlled to ≤140/90
- Ability to provide informed consent before any trial related activities are conducted.
Who cannot join
- If a patient is on statin, need to be on a stable dose for a month.
- Biopsy proven diagnosis of glomerular disease/glomerulonephritis
- Active smokers,
- Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
- Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
- Hypersensitivity to empagliflozin or finerenone
Show all 12Show fewer
- Patients on dialysis
- eGFR less than 25 mL/min/1.73 m2 by the CKD-EPI equation
- Planned surgery or planned hospital admission within 5 months of participation in the study
- At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)
- Patients with prior history of diagnosis of heart failure with documented EF of less than 50.
- Proven diagnosis of Polycystic Kidney Disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Washington DC Veterans Affairs Medical Center (688)
Washington D.C., District of Columbia, 20422
Sabyasachi Sen, MD, 202-745-8303, sabyasachi.sen@va.gov
Ping Li, MD, 202-745-8000 ext. 55910, ping.li2@va.gov
About this study
Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.
Secondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).
Read the detailed description
Chronic kidney disease (CKD) is a complex medical condition imposing deleterious effects on multiple organ systems. Prevention of increased cardiovascular mortality and progression to end-stage kidney disease (ESKD) are two major unmet medical needs in patients with CKD, with or without diabetes mellitus, especially in those with albuminuria. In patients with Diabetic Kidney Disease (DKD), the cornerstone of management includes blood pressure control, proteinuria management, maintenance of normal body weight, dietary adherence, and avoidance of nephrotoxic drugs. The management of DKD has undergone extensive changes with the advent of several foundational classes of guideline-based medical therapies (GDMT) for DKD. These include SGLT2i, GLP1-RAs along with Renin-Angiotensin System-inhibitors (RASi). While the benefits of the SGLT2i class of diabetes medications such as Empagliflozin for cardio-kidney outcomes in CKD are well recognized from the landmark EMPA-REG trial, there is less understood in terms of mechanisms of benefit, especially in high-risk patient phenotypes for progression to kidney failure, such as APOL1 positive gene mutation. The results from the recent FIDELIO-DKD and FIGARO-DKD studies showed that finerenone (an aldosterone receptor inhibitor) resulted in a decreased risk of cardiovascular events and slows down CKD progression in patients with type 2 diabetes (T2DM). This was a significant breakthrough and adds an additional class of medication for the treatment of DKD. However, the generalizability of the findings was limited as only 4.7% of the patients were African-American.
The Veterans Health Administration is the largest integrated healthcare system in the USA providing a comprehensive database of patients with CKD. The Nephrology and Endocrinology divisions at DC VAMC manage 175 new CKD patients each month (of whom 70% have diabetes) and 95% are African Americans. African Americans suffer from CKD at significantly higher rates and account for more than 35% of all patients receiving dialysis in the United States. Aggressive management with newer T2DM meds with reno-protective effects is important to be started early. Recently identified genetic variants in the APOL1 gene, found mostly in African Americans may explain a significant proportion of the rising burden of albuminuric CKD in African Americans. APOL1 risk variants G1 and G2 are trypanolytic factors that protect against trypanosomiasis in continental Africa but are associated with a significantly higher risk for the development of podocytopathy and ultimately progressive CKD. Though CKD is quite prevalent in African American patients, the precise mechanism of APOL1 risk variants leading to the progression of DKD in this patient population is unknown and requires further investigation. Interestingly the studies on APOL1 nephropathy have established an association with podocytopathy. Abnormalities in podocyte biology play a central role in the pathogenesis of albuminuric CKD. In CKD with albuminuria, podocyte injury is a key component in the pathophysiology of albuminuric CKD, which is also accompanied by systemic inflammation. The degree of podocyte injury is currently best assessed by kidney biopsy, which is an invasive procedure and not performed in the vast majority of patients with CKD. Therefore, the patterns and extent of podocyte injury in albuminuric CKD is less well understood. The investigators and others have shown improved endothelial function and decreased podocyte-specific urine protein injury markers production with SGLT2i in DKD. Additionally, the literature suggests close crosstalk between the glomerular vascular endothelium and the podocyte. The effect of Finerenone and SGLT2i on markers of podocyte injury, as well as markers of endothelial dysfunction (injury/inflammation) deserve further elucidation, either each medication on its own or in combination in African Americans with proteinuria.
The comparator in this study is Empagliflozin which is a standard of care in DKD. However, the investigators hypothesize that the combination will be more efficacious that either medication alone and synergistic for podocytopathy and proteinuria reversal similar to CONFIDENCE trial even in a CKD prone population of African Americans with diabetes
- Conditions
- Diabetic Kidney Disease
- Being tested
- Finerenone 10 MG, Empagliflozin 10 MG
- Keywords
- Empagliflozin, Finerenone, Empagliflozin and Finerenone combination, Podocyte Injury, Chronic Kidney Disease, Diabetic Kidney Disease, Diabetes Mellitus
- Medical subject headings
- Diabetic Nephropathies, Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone 10 MGDrug
Also called Kerendia
Take Finerenone 10 mg orally daily
Empagliflozin 10 MGDrug
Also called Jardiance
Take Empagliflozin 10 mg orally daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Active comparator | Finerenone 10mg orally daily for 4 months Receives: Drug: Finerenone 10 MG |
| Empagliflozin | Active comparator | Empagliflozin 10mg orally daily for 4 months Receives: Drug: Empagliflozin 10 MG |
| Finerenone and Empagliflozin combination | Active comparator | Take 10mg Empagliflozin daily, followed by Fineronone 10mg daily after 4 weeks or 1 month of taking empagliflozin. The combination will continue for 3 months or 12 weeks Receives: Drug: Finerenone 10 MG; Drug: Empagliflozin 10 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Exosome Assay
To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine on empagliflozin or finerenone or combination therapy. Protein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health.
Expressed as a ratio normalized
Measured: 16 weeks
Secondary outcomes (15)
Renal Function - urine
Assessing kidney function by Microalbumin/Creatinine Ratio (Proteinuria) in the urine
Measured: 16 weeks
Renal Function - serum
Estimated glomerular Filtration Rate (Egfr) assessing kidney function based on factors such as creatinine in the serum, age, sex, and ethnicity.
Measured: 16 weeks
CD34 positive Cell Migratory Function
Proportion of cells that migrate through SDF1a in a transwell assay. A larger value indicates better migratory function of the CD34+ cells.
Measured: 16 weeks
CD34 positive Cell Gene Expression
Evaluate mRNA gene expression focusing on vascular and endothelial function systemic markers which is normalized to 18s. Fold change of Gene Expression in participants with DKD relative to visit 1.
Measured: 16 weeks from visit 1
CD34+ Endothelial Cell Colony Formation Unit (CFU)
CFU count of CD34+ endothelial progenitor cells (EPCs)
Measured: 16 weeks
Arterial Stiffness - Pulse Wave Velocity (PWV)
Vessel health assessed by using arterial tonometry with the SphygmoCor CP system from ATCOR.
Measured: 16 weeks
Arterial Stiffness - Pulse Wave Analysis Augmentation Index
Augmentation index was calculated via tonometry with Sphygmocor Device from AtCor (Pulse Wave Analysis). Augmentation index is calculated as the augmentation pressure (the amplitude of the reflected pulse wave) divided by the pulse pressure (systolic - diastolic) * 100 to give a percentage of pulse pressure. The software then calculates an estimated Augmentation Index at heart rate of 75 as a form of "normalization." The higher the values the higher the cardiovascular risk.
Measured: 16 weeks
Arterial Stiffness - Pulse Wave Analysis Augmentation Pressure
Augmentation Pressure is the amplitude of the reflected pulse wave calculated via tonometry with Sphygmocor Device (Pulse Wave Analysis). The higher the values the higher the cardiovascular risk.
Measured: 16 weeks
Arterial Stiffness - Pulse Wave Analysis Augmentation Index 75
Vessel health is assessed by looking at Arterial stiffness via tonometry. Augmentation index (AI) is defined as the ratio of the augmentation pressure to the pulse pressure, times 100, to give a percentage. Augmentation index 75 normalizes this value to an estimate of the AI at a heart rate of 75bpm. We used Vascular Flow and wave measurement equipment, SphygmoCor Central Pressure system from AtCor. The higher the values the higher the cardiovascular risk.
Measured: 16 weeks
Hip to Waist Ratio
Ratio of Hip to Waist
Measured: 16 weeks
Body Composition: BMI
Body mass index measured using Biometric Impedance Scale in kilogram per square metre
Measured: 16 weeks
Body Composition: Body Fat Percent
Percent of Body Fat measured using Biometric Impedance Tanita Scale
Measured: 16 weeks
Body Composition: Body Water percent
Percent of Body Water measured using Biometric Impedance Tanita Scale
Measured: 16 weeks
Biochemistry: Hemoglobin A1C (HbA1c)
HbA1c percent
Measured: 16 weeks
Fasting Lipid Profile
Measured from a serum blood Lipid Panel: Total Cholesterol, LDL, HDL, and Triglycerides
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators propose a pilot 2-year, prospective interventional matched open-labeled study enrolling 30 African American veteran patients who come to the DC VAMC nephrology and/or: 10 subjects will be exposed to Finerenone 10mg orally daily 10 subjects will be exposed to Empagliflozin 10mg orally daily and 10 subjects will be exposed 10mg Finerenone plus 10mg Empagliflozin combination orally daily
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Sabyasachi Sen, MD, PhD, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Sabyasachi Sen, MD, PhD, Principal investigator, Washington DC VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155694
- Sponsor's protocol ID
- 1780095
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Finerenone in African American Veterans With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT07155694
- Acronym / sponsor ID
- 1780095
- Conditions
- Diabetic Kidney Disease
- Keywords
- Empagliflozin, Finerenone, Empagliflozin and Finerenone combination, Podocyte Injury, Chronic Kidney Disease, Diabetic Kidney Disease, Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Bayer
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 4 Sep 2025 (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.
Primary Objectives: To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine from African American Veterans with albuminuric stage 2 and 3 chronic diabetic kidney disease (DKD), using Empagliflozin or Finerenone or combination therapy.
Secondary Objectives: (1). Correlate changes in exosome-based PSP with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR. (2) with systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12), hs-CRP and (3) arterial stiffness measures and with (4) APOL1 mRNA expression levels in peripheral blood derived mononuclear cells (MNC).
Detailed description
Chronic kidney disease (CKD) is a complex medical condition imposing deleterious effects on multiple organ systems. Prevention of increased cardiovascular mortality and progression to end-stage kidney disease (ESKD) are two major unmet medical needs in patients with CKD, with or without diabetes mellitus, especially in those with albuminuria. In patients with Diabetic Kidney Disease (DKD), the cornerstone of management includes blood pressure control, proteinuria management, maintenance of normal body weight, dietary adherence, and avoidance of nephrotoxic drugs. The management of DKD has undergone extensive changes with the advent of several foundational classes of guideline-based medical therapies (GDMT) for DKD. These include SGLT2i, GLP1-RAs along with Renin-Angiotensin System-inhibitors (RASi). While the benefits of the SGLT2i class of diabetes medications such as Empagliflozin for cardio-kidney outcomes in CKD are well recognized from the landmark EMPA-REG trial, there is less understood in terms of mechanisms of benefit, especially in high-risk patient phenotypes for progression to kidney failure, such as APOL1 positive gene mutation. The results from the recent FIDELIO-DKD and FIGARO-DKD studies showed that finerenone (an aldosterone receptor inhibitor) resulted in a decreased risk of cardiovascular events and slows down CKD progression in patients with type 2 diabetes (T2DM). This was a significant breakthrough and adds an additional class of medication for the treatment of DKD. However, the generalizability of the findings was limited as only 4.7% of the patients were African-American.
The Veterans Health Administration is the largest integrated healthcare system in the USA providing a comprehensive database of patients with CKD. The Nephrology and Endocrinology divisions at DC VAMC manage 175 new CKD patients each month (of whom 70% have diabetes) and 95% are African Americans. African Americans suffer from CKD at significantly higher rates and account for more than 35% of all patients receiving dialysis in the United States. Aggressive management with newer T2DM meds with reno-protective effects is important to be started early. Recently identified genetic variants in the APOL1 gene, found mostly in African Americans may explain a significant proportion of the rising burden of albuminuric CKD in African Americans. APOL1 risk variants G1 and G2 are trypanolytic factors that protect against trypanosomiasis in continental Africa but are associated with a significantly higher risk for the development of podocytopathy and ultimately progressive CKD. Though CKD is quite prevalent in African American patients, the precise mechanism of APOL1 risk variants leading to the progression of DKD in this patient population is unknown and requires further investigation. Interestingly the studies on APOL1 nephropathy have established an association with podocytopathy. Abnormalities in podocyte biology play a central role in the pathogenesis of albuminuric CKD. In CKD with albuminuria, podocyte injury is a key component in the pathophysiology of albuminuric CKD, which is also accompanied by systemic inflammation. The degree of podocyte injury is currently best assessed by kidney biopsy, which is an invasive procedure and not performed in the vast majority of patients with CKD. Therefore, the patterns and extent of podocyte injury in albuminuric CKD is less well understood. The investigators and others have shown improved endothelial function and decreased podocyte-specific urine protein injury markers production with SGLT2i in DKD. Additionally, the literature suggests close crosstalk between the glomerular vascular endothelium and the podocyte. The effect of Finerenone and SGLT2i on markers of podocyte injury, as well as markers of endothelial dysfunction (injury/inflammation) deserve further elucidation, either each medication on its own or in combination in African Americans with proteinuria.
The comparator in this study is Empagliflozin which is a standard of care in DKD. However, the investigators hypothesize that the combination will be more efficacious that either medication alone and synergistic for podocytopathy and proteinuria reversal similar to CONFIDENCE trial even in a CKD prone population of African Americans with diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The investigators propose a pilot 2-year, prospective interventional matched open-labeled study enrolling 30 African American veteran patients who come to the DC VAMC nephrology and/or: 10 subjects will be exposed to Finerenone 10mg orally daily 10 subjects will be exposed to Empagliflozin 10mg orally daily and 10 subjects will be exposed 10mg Finerenone plus 10mg Empagliflozin combination orally daily
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Active comparator | Drug: Finerenone 10 MGFinerenone 10mg orally daily for 4 months |
| Empagliflozin | Active comparator | Drug: Empagliflozin 10 MGEmpagliflozin 10mg orally daily for 4 months |
| Finerenone and Empagliflozin combination | Active comparator | Drug: Finerenone 10 MG, Drug: Empagliflozin 10 MGTake 10mg Empagliflozin daily, followed by Fineronone 10mg daily after 4 weeks or 1 month of taking empagliflozin. The combination will continue for 3 months or 12 weeks |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of type 2 diabetes (HbA1C at or above 6.5%, or fasting blood glucose of more than 125 or random/ post prandial blood glucose of more than 199mg%)
- African American veterans
- Age 20-90 years
- eGFR ≥25-89 mL/min/1.73 m2 by the CKD-EPI equation)
- Albuminuria of 30 mg/g or higher
Key exclusion criteria (12 listed)
- If a patient is on statin, need to be on a stable dose for a month.
- Biopsy proven diagnosis of glomerular disease/glomerulonephritis
- Active smokers,
- Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)
- Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone 10 MGAlso: KerendiaTake Finerenone 10 mg orally daily | Drug | Finerenone, Finerenone and Empagliflozin combination |
| Empagliflozin 10 MGAlso: JardianceTake Empagliflozin 10 mg orally daily for 4 months | Drug | Empagliflozin, Finerenone and Empagliflozin combination |
Primary outcome
Urine Exosome Assay
Time frame: 16 weeks
To study podocyte specific injury markers (podocyte specific proteins, PSP) nephrin, podocalyxin and Wilms'Tumor (WT-1) protein in exosomes urine on empagliflozin or finerenone or combination therapy. Protein western analysis of Exosomes released from Kidney Podocyte is a indicator of kidney Podocyte health. Expressed as a ratio normalized
15 secondary outcomes
Renal Function - urine
Time frame: 16 weeks
Renal Function - serum
Time frame: 16 weeks
CD34 positive Cell Migratory Function
Time frame: 16 weeks
CD34 positive Cell Gene Expression
Time frame: 16 weeks from visit 1
CD34+ Endothelial Cell Colony Formation Unit (CFU)
Time frame: 16 weeks
Arterial Stiffness - Pulse Wave Velocity (PWV)
Time frame: 16 weeks
Arterial Stiffness - Pulse Wave Analysis Augmentation Index
Time frame: 16 weeks
Arterial Stiffness - Pulse Wave Analysis Augmentation Pressure
Time frame: 16 weeks
Arterial Stiffness - Pulse Wave Analysis Augmentation Index 75
Time frame: 16 weeks
Hip to Waist Ratio
Time frame: 16 weeks
Body Composition: BMI
Time frame: 16 weeks
Body Composition: Body Fat Percent
Time frame: 16 weeks
Body Composition: Body Water percent
Time frame: 16 weeks
Biochemistry: Hemoglobin A1C (HbA1c)
Time frame: 16 weeks
Fasting Lipid Profile
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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.
Sabyasachi Sen, MD, PhD principal investigator
Washington DC VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone 10 MG and Empagliflozin 10 MG in people with Diabetic Kidney Disease, run by Washington D.C. Veterans Affairs Medical Center 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 21 Aug 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabyasachi Sen, MD, PhD (202-745-8000 ext. 55810, sabyasachi.sen@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Exosome Assay (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2026.