Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT05719714
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG [Farxiga] — DRUG
    10mg (milligram) tablet to be taken orally once daily for 6 months. Manufacturer: Astrazeneca. Study drug will be stored and dispensed by the Interventional Drug Service Pharmacy at Northwestern University.

Study Details

The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease.

Key Dates

Start date
Jan 16, 2024
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention group
    Thirty individuals will be randomized to dapagliflozin 10mg to be taken daily for six months.
  • No Intervention: Standard of Care group
    Thirty individuals will be randomized to standard of care treatment.

Primary Outcome Measure

Left ventricular longitudinal strain (LVLS) [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60607
Rupal C Mehta, MD
312-503-1536
Tamara Isakova, MD
312-926-2000
Rupal Mehta, MD (PRINCIPAL_INVESTIGATOR)
Tamara Isakova, MD (SUB_INVESTIGATOR)

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