Non-diabetic Chronic Kidney DiseasePhase 2EMPA-CKDNCT07060417
Vascular Effects of SGLT2i in Non-diabetic CKD
A Phase 2 study testing Empagliflozin in people with Non-diabetic Chronic Kidney Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Empagliflozin, a sodium-glucose co-transporter 2 inhibitor (SGLT2i), is a novel diabetic medication that reduces the risk of progression of chronic kidney disease (CKD) and heart failure and improves exercise tolerance regardless of the diabetes status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-diabetic Chronic Kidney Disease
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eGFR (estimated glomerular filtration rate) 20-59 mL/min (milliliters per minute)
- albuminuria <300 mg/g (milligrams per gram)
Who cannot join
- Type 1 or 2 diabetes mellitus
- expected to start dialysis or receive kidney transplantation or die within 4 months
- prior therapy with SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors) within the previous year
- unable to participate in the physical function tests (hand grip, walk)
- infections requiring intravenous antibiotic treatment
- malignancy requiring systemic therapy
Show all 11Show fewer
- extremity skin ulceration requiring active therapy
- history of Fournier's gangrene
- severe hypoglycemia requiring external assistance within the past one year
- known allergy to empagliflozin
- pregnancy
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
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148-0001
Monique Cho, MD, (801) 582-1565, monique.cho@va.gov
Monique Cho, MD
About this study
Official title: The Effects of SGLT2 Inhibition on Vascular Health and Physical Function in Veterans With CKD
Empagliflozin, a sodium-glucose co-transporter 2 inhibitor (SGLT2i), is a novel diabetic medication that reduces the risk of progression of chronic kidney disease (CKD) and heart failure and improves exercise tolerance regardless of the diabetes status. One of the important ways that empagliflozin improves health may be through its benefits on blood vessels. The effects of empagliflozin on blood vessels and physical function have not been examined in patients with chronic kidney disease, and it is less clear if empagliflozin may be beneficial in patients with chronic kidney disease without heavy urinary protein leakage. The investigators will examine if empagliflozin can improve blood vessel function and exercise tolerance in Veterans with chronic kidney disease without heavy urinary protein leakage.
Read the detailed description
Overall Strategy: The investigators propose a randomized, double-blind, placebo-controlled, phase-II study in 52 Veterans with non-diabetic CKD without heavy albuminuria (<300 mg/g) and eGFR 20-59 mL/min/1.73m2 to investigate if empagliflozin, a selective SGLT2i, can improve vascular function, functional capacity, and plasma biomarkers of inflammation, oxidative stress, and nitric oxide (NO). Veterans will be recruited from the Salt Lake City VA and randomized to 10 mg of empagliflozin or placebo at 1:1 ratio and treated for 16 weeks.
Overarching Hypothesis: SGLT2 inhibition improves endothelial function in both macro- and micro-vasculature, in part, by mitigating inflammation and oxidative stress and augmenting NO bioavailability in patients with CKD, even in the absence of heavy albuminuria. The improved vascular function contributes to increased functional capacity.
Specific Aim 1: Comprehensively evaluate the efficacy of empagliflozin to improve vascular health, as determined by conduit artery endothelium-dependent vasodilation (flow-mediated dilation, FMD), peripheral microvasculature reactivity (passive limb movement, PLM), and arterial stiffness (carotid-femoral pulse wave velocity, PWV), in non-diabetic Veterans with CKD and albuminuria <300 mg/g.
Specific Aim 2: Evaluate the efficacy of empagliflozin to improve functional capacity using (a) handgrip exercise and (b) mobility tests (Timed Up-and-Go test, gait speeds, and 6-minute walk).
Specific Aim 3 (Exploratory): Evaluate the efficacy of empagliflozin to (a) reduce plasma biomarkers of systemic inflammation (C-reactive protein, interleukin-6, tumor necrosis factor- ) and oxidative stress (free radical concentration assessed by electron paramagnetic resonance spectroscopy) and (b) increase plasma NO, as reflected by plasma nitrite and nitrosyl hemoglobin levels.
- Conditions
- Non-diabetic Chronic Kidney Disease
- Being tested
- Empagliflozin, Placebo
- Keywords
- CKD, SGLT2 inhibitor, endothelial function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance
Empagliflozin 10 mg, encapsulated to match the placebo, will be used.
PlaceboDrug
Matching placebo will be used.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo will be encapsulated to look identical to the study drug. Receives: Drug: Placebo |
| Empagliflozin | Other | Matching 10-mg empagliflozin dose will be used. Receives: Drug: Empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelium-dependent vasodilation as measured by flow mediated dilation (FMD)
Brachial artery FMD will be used to assess if empagliflozin can improve endothelial function of conduit arteries in the upper limb. Brachial artery FMD outcome will be quantified as the maximal change in brachial artery diameter during the two-minute period after cuff release, expressed as a percentage increase from the pre-occlusion value (%FMD).
Measured: baseline, 8 weeks, 16 weeks
Secondary outcomes (4)
Change in leg blood flow area-under-the-curve (LBF AUC) by Passive Leg Movement (PLM)
PLM measures the movement-induced increase of blood flow mediated mostly by nitric oxide in feed arteries and microvascular beds of the leg. The total hyperemic response to PLM, expressed as LBF AUC, will be used as the main PLM endpoint.
Measured: baseline, 8 weeks, 16 weeks
Changes in aortic stiffness as measured by carotid-femoral pulse wave velocity (PWV)
Carotid-femoral PWV is the gold standard for non-invasive assessment of central arterial stiffness, and our study will follow the established guidelines.
Measured: baseline, 8 weeks, 16 weeks
Changes in functional capacity as measured by handgrip exercise
Handgrip strength will be measured during the maximal voluntary contraction using a handgrip dynamometer. The highest value of three maximal contractions will be used.
Measured: baseline, 8 weeks, 16 weeks
Mobility
Timed Up-and-Go test will be used to assess sequential mobility tasks that incorporate walking and turning. The gait speed test over a 10-meter distance will be assessed during both comfortable and fast-gait speeds. The 6-minute walk test will measure the total distance covered during a 6-minute duration.
Measured: baseline, 8 weeks, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Oct 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-diabetic Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, placebo-controlled, phase-II study in 52 Veterans with non-diabetic CKD without heavy albuminuria (\<300 mg/g) and eGFR 20-59 mL/min/1.73m2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Monique Cho, MD, Principal investigator, VA Salt Lake City Health Care System, Salt Lake City, UT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060417
- Sponsor's protocol ID
- NEPH-006-24F
- Acronym
- EMPA-CKD
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of SGLT2 Inhibition on Vascular Health and Physical Function in Veterans With CKD
- ClinicalTrials.gov ID
- NCT07060417
- Acronym / sponsor ID
- EMPA-CKD / NEPH-006-24F
- Conditions
- Non-diabetic Chronic Kidney Disease
- Keywords
- CKD, SGLT2 inhibitor, endothelial function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 11 Jul 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.
Empagliflozin, a sodium-glucose co-transporter 2 inhibitor (SGLT2i), is a novel diabetic medication that reduces the risk of progression of chronic kidney disease (CKD) and heart failure and improves exercise tolerance regardless of the diabetes status. One of the important ways that empagliflozin improves health may be through its benefits on blood vessels. The effects of empagliflozin on blood vessels and physical function have not been examined in patients with chronic kidney disease, and it is less clear if empagliflozin may be beneficial in patients with chronic kidney disease without heavy urinary protein leakage. The investigators will examine if empagliflozin can improve blood vessel function and exercise tolerance in Veterans with chronic kidney disease without heavy urinary protein leakage.
Detailed description
Overall Strategy: The investigators propose a randomized, double-blind, placebo-controlled, phase-II study in 52 Veterans with non-diabetic CKD without heavy albuminuria (<300 mg/g) and eGFR 20-59 mL/min/1.73m2 to investigate if empagliflozin, a selective SGLT2i, can improve vascular function, functional capacity, and plasma biomarkers of inflammation, oxidative stress, and nitric oxide (NO). Veterans will be recruited from the Salt Lake City VA and randomized to 10 mg of empagliflozin or placebo at 1:1 ratio and treated for 16 weeks.
Overarching Hypothesis: SGLT2 inhibition improves endothelial function in both macro- and micro-vasculature, in part, by mitigating inflammation and oxidative stress and augmenting NO bioavailability in patients with CKD, even in the absence of heavy albuminuria. The improved vascular function contributes to increased functional capacity.
Specific Aim 1: Comprehensively evaluate the efficacy of empagliflozin to improve vascular health, as determined by conduit artery endothelium-dependent vasodilation (flow-mediated dilation, FMD), peripheral microvasculature reactivity (passive limb movement, PLM), and arterial stiffness (carotid-femoral pulse wave velocity, PWV), in non-diabetic Veterans with CKD and albuminuria <300 mg/g.
Specific Aim 2: Evaluate the efficacy of empagliflozin to improve functional capacity using (a) handgrip exercise and (b) mobility tests (Timed Up-and-Go test, gait speeds, and 6-minute walk).
Specific Aim 3 (Exploratory): Evaluate the efficacy of empagliflozin to (a) reduce plasma biomarkers of systemic inflammation (C-reactive protein, interleukin-6, tumor necrosis factor- ) and oxidative stress (free radical concentration assessed by electron paramagnetic resonance spectroscopy) and (b) increase plasma NO, as reflected by plasma nitrite and nitrosyl hemoglobin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, phase-II study in 52 Veterans with non-diabetic CKD without heavy albuminuria (<300 mg/g) and eGFR 20-59 mL/min/1.73m2.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThe placebo will be encapsulated to look identical to the study drug. |
| Empagliflozin | Other | Drug: EmpagliflozinMatching 10-mg empagliflozin dose will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- eGFR (estimated glomerular filtration rate) 20-59 mL/min (milliliters per minute)
- albuminuria <300 mg/g (milligrams per gram)
Key exclusion criteria (11 listed)
- Type 1 or 2 diabetes mellitus
- expected to start dialysis or receive kidney transplantation or die within 4 months
- prior therapy with SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors) within the previous year
- unable to participate in the physical function tests (hand grip, walk)
- infections requiring intravenous antibiotic treatment
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 |
|---|---|---|
| EmpagliflozinAlso: JardianceEmpagliflozin 10 mg, encapsulated to match the placebo, will be used. | Drug | Empagliflozin |
| PlaceboMatching placebo will be used. | Drug | Placebo |
Primary outcome
Change in endothelium-dependent vasodilation as measured by flow mediated dilation (FMD)
Time frame: baseline, 8 weeks, 16 weeks
Brachial artery FMD will be used to assess if empagliflozin can improve endothelial function of conduit arteries in the upper limb. Brachial artery FMD outcome will be quantified as the maximal change in brachial artery diameter during the two-minute period after cuff release, expressed as a percentage increase from the pre-occlusion value (%FMD).
4 secondary outcomes
Change in leg blood flow area-under-the-curve (LBF AUC) by Passive Leg Movement (PLM)
Time frame: baseline, 8 weeks, 16 weeks
Changes in aortic stiffness as measured by carotid-femoral pulse wave velocity (PWV)
Time frame: baseline, 8 weeks, 16 weeks
Changes in functional capacity as measured by handgrip exercise
Time frame: baseline, 8 weeks, 16 weeks
Mobility
Time frame: baseline, 8 weeks, and 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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Monique Cho, MD principal investigator
VA Salt Lake City Health Care System, Salt Lake City, UT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin in people with Non-diabetic Chronic Kidney Disease, run by VA Office of Research and Development 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 2 inclusion and 11 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 20 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Monique Cho, MD ((801) 582-1565, monique.cho@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelium-dependent vasodilation as measured by flow mediated dilation (FMD) (time frame: baseline, 8 weeks, 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 20 Aug 2026.