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Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)

CompletedPhase 2

Sponsor: University Hospital, Rouen

Conditions: Renal Insufficiency, Chronic

Interventions: Dapagliflozin 10Mg Tab, Placebo, impedance cardiography, Applanation tonometry, post-ischemic hyperemia of forearm

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Locations (2)

Bois-Guillaume, France
Rouen, France