Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)

Prior treatment

• Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to 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
• 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

Other illness

• Recessive or autosomal dominant polycystic kidney disease
• History of organ transplantation
• Patients with NYHA class IV congestive heart failure at the time of enrolment
• 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)
• 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.

Lab values

• Type 1 and type 2 diabetes (fasting glycemia≥126 mg/dL or use of oral hypoglycemic agents or insulin)
• Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
• Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor

Other

• Lupus nephritis
• Body weight \> 35 kg/m²
• 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

• 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