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
- Chronic Kidney Diseases
- Heart Failure
- Heart Failure With Preserved Ejection Fraction
- Kidney Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin 10 MG [Farxiga] — DRUG10mg (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 groupThirty individuals will be randomized to dapagliflozin 10mg to be taken daily for six months.
- No Intervention: Standard of Care groupThirty individuals will be randomized to standard of care treatment.
Primary Outcome Measure
Left ventricular longitudinal strain (LVLS) [ Time Frame: 6 months ]
Central Contacts
- Rupal Mehta, MD(312) 503-1536
- Tamara Isakova, MD(312) 503-6921
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60607 | Rupal Mehta, MD (PRINCIPAL_INVESTIGATOR) Tamara Isakova, MD (SUB_INVESTIGATOR) |
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