Renal Mechanism of SGLT2 Inhibition
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT05507892
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Diabetic Kidney Disease
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- canagliflozin — DRUGCanagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It is a used to treat type 2 diabetes. Canagliflozin lowers blood sugars by causing the kidneys to excrete more glucose in the urine.
- Aminohippurate Sodium Inj 20% — DRUGDiagnostic aid/agent used to measure renal plasma flow (RPF) PAH (Basic Pharma, Geleen, Netherlands) has been used to measure RPF in human research for 7 decades, and is very well tolerated and generally recognized as safe with low toxicity.
Study Details
Canagliflozin is an oral drug which is currently approved for use in patients with type 2 diabetes by the US Food and Drug Administration (FDA). Canagliflozin acts by increasing salt and sugar loss in the urine, and has shown to protect heart, kidney, and blood vessel function in patients with type 2 diabetes. However, it is unknown how canagliflozin protects the kidneys from disease. Therefore, this study plans to learn more about how canagliflozin works to protect against diabetic kidney disease in adults with type 2 diabetes. This study will use state-of-the-art kidney imaging, kidney biopsies and detailed testing of kidney function to determine the mechanisms of protection afforded by canagliflozin.
Key Dates
- Start date
- Oct 10, 2022
- Status verified
- May 2026
- Primary completion
- Dec 15, 2026
- Completion
- Dec 15, 2026
Study Design
- Enrollment
- 45 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentParticipants who will receive 100 mg of canagliflozin daily for six (6) months in addition to standard of care.
Primary Outcome Measure
Glomerular basement membrane (GBM) width and mesangial expansion [ Time Frame: 6 months ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Denver | Aurora | Colorado | 80045 | - |
| University of Michigan | Ann Arbor | Michigan | 48109 | - |
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