Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)

NCT04930549 | Completed Phase 2 DMC

• 1 other identifier: 2021/0188/HP
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Renal Insufficiency, Chronic

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (11)

• Change from baseline of arterial stiffness using applanation tonometry

  12 weeks

• Change from baseline of carotid artery geometry using echography (1)

  12 weeks

• Change from baseline of carotid artery geometry using echography (2)

  12 weeks

• Change from baseline of cardiac function by impedance cardiography (1)

  12 weeks

• Change from baseline of cardiac function by impedance cardiography (2)

  12 weeks

Study Arms (2)

Dapagliflozin 10Mg Tab

EXPERIMENTAL

Dapagliflozin 10 mg film-coated tablets

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

Drug: Placebo; Procedure: impedance cardiography; Procedure: Applanation tonometry; Procedure: post-ischemic hyperemia of forearm; Procedure: haemodynamics parameters

Interventions

Dapagliflozin 10Mg Tab DRUG

Patients receive dapagliflozin 10mg tablets once a day during 12 weeks

Dapagliflozin 10Mg Tab

Placebo DRUG

Patients receive placebo tablets once a day during 12 weeks

Placebo

impedance cardiography PROCEDURE

impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function

Dapagliflozin 10Mg Tab; Placebo

Applanation tonometry PROCEDURE

Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness

Dapagliflozin 10Mg Tab; Placebo

post-ischemic hyperemia of forearm PROCEDURE

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®)

Dapagliflozin 10Mg Tab; Placebo

haemodynamics parameters PROCEDURE

haemodynamics parameters will be evaluated using automatic oscillometric recorder

Dapagliflozin 10Mg Tab; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 intolerant to ACE inhibitors or ARBs

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• AstraZeneca: collaborator

Study Sites (2)

Department of Nephrology

Bois-Guillaume, 76230, France

Location

Department of Pharmacology

Rouen, 76031, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dominique Guerrot, MD, PhD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

• Jeremy Bellien, PharmD, PhD

  University Hospital, Rouen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 18, 2021
• Study Start: October 18, 2022
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: February 6, 2026

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)