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Impact of dapagliflozin on vascular function in chronic kidney disease patients - (DAPA-VASC)
EU CTIS ID: 2024-514887-14-00
What this study is testing
To demonstrate that 12-week treatment with dapagliflozin improves endothelium-dependent flow-mediated dilatation of peripheral conduit arteries during short-term increase in blood flow in chronic kidney disease patients
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 unable to take angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).
- Patient having read and understood the information letter and signed the Informed Consent Form
- For women: a. Women of childbearing potential : i. Effective contraception according to CTFG contraception recommendations (V1.1 21/09/2020) since at least 4 weeks before randomization and during treatment, and; ii. Negative blood pregnancy test; b. Women surgically sterile (absence of ovaries and/or uterus); c. Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit). Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods must always be supplemented with the use of a spermicide.
- Patient able to comply with the study protocol, in the investigator's judgment
You likely can't join if
- Type 1 and type 2 diabetes (fasting glycemia ≥ 126 mg/dL or use of oral hypoglycemic agents or insulin)
- 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
- Receiving phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil or other) or riociguat (due to the risk of hypotension potentiation with GTN spray).
- 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
See the full eligibility criteria
Who can 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 unable to take angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).
- Patient having read and understood the information letter and signed the Informed Consent Form
- For women: a. Women of childbearing potential : i. Effective contraception according to CTFG contraception recommendations (V1.1 21/09/2020) since at least 4 weeks before randomization and during treatment, and; ii. Negative blood pregnancy test; b. Women surgically sterile (absence of ovaries and/or uterus); c. Postmenopausal women (non-medically induced amenorrhea for at least 12 months prior to the inclusion visit). Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods must always be supplemented with the use of a spermicide.
- Patient able to comply with the study protocol, in the investigator's judgment
- Patient affiliated with, or beneficiary of a social security (health insurance) category.
What rules you out
- Type 1 and type 2 diabetes (fasting glycemia ≥ 126 mg/dL or use of oral hypoglycemic agents or insulin)
- 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
- Receiving phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil or other) or riociguat (due to the risk of hypotension potentiation with GTN spray).
- 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 pancreatitis
- History of frequent genital mycotic infections (> 2 during the last 12 months)
- Patients whose conditions lead to reduced food absorption or severe dehydration
- Current pregnancy OR women who are breast-feeding
- Contraindications to NATISPRAY® 0.30mg/dose, solution for oral spray : - Hypersensitivity to nitrates or to any of the excipients, - State of shock, severe hypotension, - In combination with sildenafil, taladafil, vardenafil, avanafil and riociguat - Obstructive cardiomyopathy, - Inferior site myocardial infarction with extension to the right ventricle, acute phase, except when there is a sign of left ventricular failure, - Intracranial hypertension
- Contra-indication to FORXIGA 10 mg film-coated tablets: hypersensitivity to dapagliflozin or to any of the excipients
- Participation in another clinical study with an investigational product during the last 4 weeks prior to enrolment
- Patients with reduced insulin levels
- Patients with increased insulin requirements due to an acute medical condition, surgery or excessive alcohol consumption
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.