Renal Insufficiency, ChronicPhase 2DAPAVASCNCT04930549
Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)
A Phase 2 study testing Dapagliflozin 10Mg Tab, impedance cardiography and Applanation tonometry in people with Renal Insufficiency, Chronic, run by University Hospital, Rouen at 2 sites in France.
Trial summary
This study aims to determine whether dapaglfiflozin 12-week administration is associated with a beneficial impact on the vasculature of patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Dapagliflozin 10Mg Tab, impedance cardiography and Applanation tonometry
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Oct 2022to 23 Sep 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease (eGFR ≥25 and ≤60 mL/min/1.73m² by CKD-EPI)
- Age ≥ 18 years
- Receiving a stable dose of an ACE inhibitor or ARB for at least 12 weeks before screening or patients who were documented to be intolerant to ACE inhibitors or ARBs
Who cannot join
- Type 1 and type 2 diabetes (fasting glycemia≥126 mg/dL or use of oral hypoglycemic agents or insulin)
- Recessive or autosomal dominant polycystic kidney disease
- Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
- Lupus nephritis
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- History of organ transplantation
Show all 18Show fewer
- Body weight > 35 kg/m²
- Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- Patients with NYHA class IV congestive heart failure at the time of enrolment
- Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
- Active malignancy requiring treatment at the time of enrolment or is planned to undergo any treatment after randomization
- Severe hepatic impairment (Child-Pugh class C)
- History of frequent genital mycotic infections (>2)
- Current pregnancy OR women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or exploration visits OR women who are breast-feeding
- Contraindications to use glyceryl trinitrate (in particular allergy to nitrates or concomitant use of vasodilators)
- Participation in another clinical study with an investigational product during the last month prior to enrolment
- Inability of the patient, in the opinion of the investigator, to understand and/or comply with procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Nephrology
Bois-Guillaume, 76230
Department of Pharmacology
Rouen, 76031
About this study
Official title: Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients
This study aims to determine whether dapaglfiflozin 12-week administration is associated with a beneficial impact on the vasculature of patients with chronic kidney disease.
Read the detailed description
A prospective, randomized, double-blind studies evaluating the impact of once-daily dapagliflozin 10 mg versus placebo for 12 weeks on endothelial function, as primary endpoint, will be conducted in 56 patients with chronic kidney disease (eGFR ≥25 and ≤60 mL/min/1.73m2 by CKD-EPI) and without diabetes (fasting glycemia≥1.26 mg/dL, oral hypoglycemic agents or insulin) on top of standard treatment (n=27 per group). Indexes of arterial stiffness, cardiovascular coupling, cardiac function and plasma concentrations of endothelial, inflammatory and oxidative stress biomarkers will be assessed as secondary endpoints. Patients will be recruited in the Departments of Cardiology and Nephrology of Rouen University Hospital. The study will include an inclusion visit (V1), 2 exploration visits performed before (V2) and 12 weeks (V3) after treatment initiation, and 1 output study (V4).
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Dapagliflozin 10Mg Tab, Placebo, impedance cardiography, Applanation tonometry, post-ischemic hyperemia of forearm
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Patients receive dapagliflozin 10mg tablets once a day during 12 weeks
PlaceboDrug
Patients receive placebo tablets once a day during 12 weeks
impedance cardiographyProcedure or surgery
impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
Applanation tonometryProcedure or surgery
Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
post-ischemic hyperemia of forearmProcedure or surgery
An arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®)
haemodynamics parametersProcedure or surgery
haemodynamics parameters will be evaluated using automatic oscillometric recorder
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10Mg Tab | Experimental | Dapagliflozin 10 mg film-coated tablets Receives: Drug: Dapagliflozin 10Mg Tab; Procedure: impedance cardiography; Procedure: Applanation tonometry; Procedure: post-ischemic hyperemia of forearm; Procedure: haemodynamics parameters |
| Placebo | Placebo comparator | Identical film-coated tablets without dapagliflozin Receives: Drug: Placebo; Procedure: impedance cardiography; Procedure: Applanation tonometry; Procedure: post-ischemic hyperemia of forearm; Procedure: haemodynamics parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of brachial artery endothelial function using echography
Change in brachial artery flow-mediated dilatation in response to post-ischemia hyperemia using difference of brachial artery diameter
Measured: 12 weeks
Secondary outcomes (11)
Change from baseline of arterial stiffness using applanation tonometry
Change in carotid-to-femoral pulse wave velocity
Measured: 12 weeks
Change from baseline of carotid artery geometry using echography (1)
Change in carotid diastolic diameter
Measured: 12 weeks
Change from baseline of carotid artery geometry using echography (2)
Change in carotid intima-media thickness using echography
Measured: 12 weeks
Change from baseline of cardiac function by impedance cardiography (1)
Change in cardiac output
Measured: 12 weeks
Change from baseline of cardiac function by impedance cardiography (2)
Change in stroke volume
Measured: 12 weeks
Change from baseline of cardiac function by impedance cardiography (3)
Change in ejection fraction
Measured: 12 weeks
Change from baseline of cardiac function by impedance cardiography (4)
Change in end-diastolic volume
Measured: 12 weeks
Change from baseline of cardiac function by impedance cardiography (5)
Change in total peripheral resistance,
Measured: 12 weeks
Change from baseline of cardiac function by impedance cardiography (6)
Change in left ventricular end-systolic elastance
Measured: 12 weeks
Change from baseline of epoxyeicosatrienoic acid bioavailability
Change in epoxyeicosatroenoic acid bioavailibility during heating
Measured: 12 weeks
Change from baseline of plasma NO bioavailability
Change in plasma nitrite bioavailibility during heating
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start18 Oct 2022
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Dominique Guerrot, MD, PhD, Principal investigator, University Hospital, RouenJeremy Bellien, PharmD, PhD, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930549
- Sponsor's protocol ID
- 2021/0188/HP
- Acronym
- DAPAVASC
- Status last verified
- Nov 2022
- First submitted
- 3 Jun 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT04930549
- Acronym / sponsor ID
- DAPAVASC / 2021/0188/HP
- Conditions
- Renal Insufficiency, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 18 Jun 2021 (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.
This study aims to determine whether dapaglfiflozin 12-week administration is associated with a beneficial impact on the vasculature of patients with chronic kidney disease.
Detailed description
A prospective, randomized, double-blind studies evaluating the impact of once-daily dapagliflozin 10 mg versus placebo for 12 weeks on endothelial function, as primary endpoint, will be conducted in 56 patients with chronic kidney disease (eGFR ≥25 and ≤60 mL/min/1.73m2 by CKD-EPI) and without diabetes (fasting glycemia≥1.26 mg/dL, oral hypoglycemic agents or insulin) on top of standard treatment (n=27 per group). Indexes of arterial stiffness, cardiovascular coupling, cardiac function and plasma concentrations of endothelial, inflammatory and oxidative stress biomarkers will be assessed as secondary endpoints. Patients will be recruited in the Departments of Cardiology and Nephrology of Rouen University Hospital. The study will include an inclusion visit (V1), 2 exploration visits performed before (V2) and 12 weeks (V3) after treatment initiation, and 1 output study (V4).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10Mg Tab | Experimental | Drug: Dapagliflozin 10Mg Tab, Procedure: impedance cardiography, Procedure: Applanation tonometry, Procedure: post-ischemic hyperemia of forearm, Procedure: haemodynamics parametersDapagliflozin 10 mg film-coated tablets |
| Placebo | Placebo comparator | Drug: Placebo, Procedure: impedance cardiography, Procedure: Applanation tonometry, Procedure: post-ischemic hyperemia of forearm, Procedure: haemodynamics parametersIdentical film-coated tablets without dapagliflozin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic kidney disease (eGFR ≥25 and ≤60 mL/min/1.73m² by CKD-EPI)
- Age ≥ 18 years
- Receiving a stable dose of an ACE inhibitor or ARB for at least 12 weeks before screening or patients who were documented to be intolerant to ACE inhibitors or ARBs
Key exclusion criteria (18 listed)
- Type 1 and type 2 diabetes (fasting glycemia≥126 mg/dL or use of oral hypoglycemic agents or insulin)
- Recessive or autosomal dominant polycystic kidney disease
- Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
- Lupus nephritis
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
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 |
|---|---|---|
| Dapagliflozin 10Mg TabPatients receive dapagliflozin 10mg tablets once a day during 12 weeks | Drug | Dapagliflozin 10Mg Tab |
| PlaceboPatients receive placebo tablets once a day during 12 weeks | Drug | Placebo |
| impedance cardiographyimpedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function | Procedure or surgery | Dapagliflozin 10Mg Tab, Placebo |
| Applanation tonometryApplanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness | Procedure or surgery | Dapagliflozin 10Mg Tab, Placebo |
| post-ischemic hyperemia of forearmAn arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®) | Procedure or surgery | Dapagliflozin 10Mg Tab, Placebo |
| haemodynamics parametershaemodynamics parameters will be evaluated using automatic oscillometric recorder | Procedure or surgery | Dapagliflozin 10Mg Tab, Placebo |
Primary outcome
Change from baseline of brachial artery endothelial function using echography
Time frame: 12 weeks
Change in brachial artery flow-mediated dilatation in response to post-ischemia hyperemia using difference of brachial artery diameter
11 secondary outcomes
Change from baseline of arterial stiffness using applanation tonometry
Time frame: 12 weeks
Change from baseline of carotid artery geometry using echography (1)
Time frame: 12 weeks
Change from baseline of carotid artery geometry using echography (2)
Time frame: 12 weeks
Change from baseline of cardiac function by impedance cardiography (1)
Time frame: 12 weeks
Change from baseline of cardiac function by impedance cardiography (2)
Time frame: 12 weeks
Change from baseline of cardiac function by impedance cardiography (3)
Time frame: 12 weeks
Change from baseline of cardiac function by impedance cardiography (4)
Time frame: 12 weeks
Change from baseline of cardiac function by impedance cardiography (5)
Time frame: 12 weeks
Change from baseline of cardiac function by impedance cardiography (6)
Time frame: 12 weeks
Change from baseline of epoxyeicosatrienoic acid bioavailability
Time frame: 12 weeks
Change from baseline of plasma NO bioavailability
Time frame: 12 weeks
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 6 Feb 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. This study is not recruiting at the moment.
Dominique Guerrot, MD, PhD principal investigator
University Hospital, Rouen
Jeremy Bellien, PharmD, PhD study director
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10Mg Tab, impedance cardiography and Applanation tonometry in people with Renal Insufficiency, Chronic, run by University Hospital, Rouen at 2 sites in France.
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 3 inclusion and 18 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
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?
Change from baseline of brachial artery endothelial function using echography (time frame: 12 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 6 Feb 2026.