NCT05507892
Renal Mechanism of SGLT2 Inhibition
Active, Not Recruiting
PHASE2Ages 18–80InterventionalTreatmentUniversity of Colorado, DenverInvestigator-initiated
~45 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:canagliflozinAminohippurate Sodium Inj 20%
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glomerular basement membrane (GBM) width and mesangial expansion
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
2 sites across 2 statesColorado1
Michigan1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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)
What this trial measures
- Glomerular basement membrane (GBM) width and mesangial expansion6 months
measured by morphometric examination of kidney tissue
- Kidney Transcript Changes6 months
Molecular changes measured by change in transcripts as assessed by single-cell RNA sequencing of kidney biopsy specimens