Kidney shield: diabetes Drug's hidden powers revealed?
NCT ID NCT05507892
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how canagliflozin (Invokana), a diabetes drug, protects the kidneys in people with type 2 diabetes. Researchers will use advanced imaging, kidney biopsies, and function tests to uncover the mechanisms. The trial involves 45 adults and aims to explain the drug's kidney-protective effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- canagliflozin (Invokana)
- What this could lead to
- If successful, this could reveal exactly how canagliflozin protects the kidneys, potentially leading to better treatments for diabetic kidney disease.
- What could go wrong
- This is a small, early-phase study focused on understanding mechanisms, not proving clinical benefit. Results may not lead to new treatments or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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45 people
The number who actually took part.
- Started
-
Oct 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged 18-80 years. The lower age limit was set so renal function test results would not reflect changes associated with growth. * Diagnosis of type 2 diabetes for ≥ 3 years. * Estimated GFR \>45 and \< 90 ml/min/1.73m2 as determined from the CKD-EPI equation using serum creatinine (Levey et al., 2009). * A screening urinary albumin-to-creatinine ratio \<3000 mg/g. * Willingness to participate after receiving a thorough explanation of the study. * Participants receiving a RAAS inhibitor must have been receiving the drug at maximum tolerable dose for at least 3 months prior to the study baseline examination. * Participants receiving a GLP-1 receptor agonist must have been receiving the drug for at least 3 months prior to the study baseline examination. Exclusion Criteria: * Clinically significant disorders of the liver \[cirrhosis, portal hypertension, hepatitis, increased bilirubin (≥1.5 mg/dl), active or uncontrolled cardiovascular disease, symptomatic peripheral vascular disease, (i.e. intermittent claudication), pulmonary diseases (including uncontrolled asthma and restrictive or obstructive lung disease requiring therapy), renal-urinary disorders (calculi, urinary tract obstruction, glomerulonephritis, chronic infection), gastrointestinal disorders (nausea, vomiting, diarrhea or anorexia sufficient to cause weight loss or wasting), or hematocrit levels ≤30 percent in women or ≤35 percent in men. * Prior treatment with SGLT2 inhibitors and unable to perform a wash-out. * Renovascular or malignant hypertension; uncontrolled hypertension (systolic blood pressure ≥150 or diastolic ≥90 mm Hg) * Hematuria of unknown etiology. Prior to entry into the study, any participant with hematuria should be evaluated, the etiology established and documented, and treatment rendered as appropriate. * Chronic debilitating disorders with or without treatment (e.g., systemic lupus erythematosus \[SLE\], cancer, amyloidosis, and chronic infection) that would interfere with the assessment of kidney function or that might reduce the chances of survival for a sufficient length of time to evaluate the efficacy of treatment. * Currently receiving a drug regimen that includes steroids, immunosuppressants, or investigational new drugs not associated with this trial. * Pregnancy. SGLT2 inhibitors are not recommended during the second or third trimester of pregnancy. Moreover, we do not wish to expose pregnant women to conscious sedation that is used during the kidney biopsies or to the intravenous filtration markers iohexol and p-aminohippurate needed for the renal clearance studies. Women of childbearing potential must have a negative pregnancy test prior to entry and every 2 months during the study and agree to using an effective form of contraception throughout the study, such as the oral contraceptive pill or an intrauterine device. Women who are planning a pregnancy in the next three years will be excluded. * Known hypersensitivity to canagliflozin or iodine. * Bleeding disorders or requirements for anticoagulation or platelet inhibitors which cannot be safely interrupted, since kidney biopsies cannot be performed safely in these individuals. * Massive obesity with body mass index ≥45 kg/m². Kidney biopsies are more technically difficult with massive obesity. * Non-diabetic kidney disease - based on clinical history or kidney biopsy examination. * History of osteoporotic fracture. * Conditions likely to interfere with informed consent or compliance with the protocol. * Single kidney; any condition with a single kidney * Kidney cortex \<1 cm (both kidneys) * Kidney length \<8 cm (both kidneys)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Colorado Denver
Aurora, Colorado, 80045, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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