Actively Recruiting
Renal Mechanism of SGLT2 Inhibition
Led by University of Colorado, Denver · Updated on 2025-07-18
40
Participants Needed
2
Research Sites
218 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
U
University of Michigan
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Renal Mechanism of SGLT2 Inhibition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years
- Diagnosis of type 2 diabetes for 3 years or more
- Estimated GFR greater than 45 and less than 90 ml/min/1.73m2
- Screening urinary albumin-to-creatinine ratio less than 3000 mg/g
- Willingness to participate after thorough explanation of the study
- Receiving a RAAS inhibitor at maximum tolerated dose for at least 3 months prior to baseline (if applicable)
- Receiving a GLP-1 receptor agonist for at least 3 months prior to baseline (if applicable)
You will not qualify if you...
- Significant liver disorders such as cirrhosis, portal hypertension, hepatitis, or increased bilirubin (≥1.5 mg/dl)
- Active or uncontrolled cardiovascular disease or symptomatic peripheral vascular disease
- Pulmonary diseases requiring therapy including uncontrolled asthma or restrictive/obstructive lung disease
- Renal-urinary disorders like kidney stones, obstruction, glomerulonephritis, or chronic infection
- Gastrointestinal disorders causing weight loss or wasting
- Low hematocrit levels (≤30% in women or ≤35% in men)
- Prior treatment with SGLT2 inhibitors without ability to wash out
- Renovascular or malignant hypertension; uncontrolled high blood pressure (systolic ≥150 or diastolic ≥90 mm Hg)
- Hematuria of unknown cause without prior evaluation
- Chronic debilitating disorders (e.g., lupus, cancer, amyloidosis, chronic infection) affecting kidney function or survival
- Current use of steroids, immunosuppressants, or investigational drugs unrelated to this trial
- Pregnancy or planning pregnancy within 3 years; women must use effective contraception and have negative pregnancy tests
- Known allergy to canagliflozin or iodine
- Bleeding disorders or inability to safely stop anticoagulation
- Massive obesity with BMI ≥45 kg/m2
- Allergy to iodine contrast or shellfish
- Non-diabetic kidney disease
- History of osteoporotic fracture
- Conditions interfering with informed consent or study compliance
- Single kidney or related conditions
- Kidney cortex thickness less than 1 cm in both kidneys
- Kidney length less than 8 cm in both kidneys
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
Jessica Kendrick, MD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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