Molecular Mechanisms of SGLT2 Inhibition in Diabetic Kidney Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
University of Colorado Denver
RECRUITING
Aurora
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Jessica Kendrick, MD, MPH
Jessica.Kendrick@CUANSCHUTZ.EDU
303-724-4837
Time Frame
Start Date: 2022-10-10
Estimated Completion Date: 2026-12-15
Participants
Target number of participants: 40
Treatments
Experimental: Treatment
Participants who will receive 100 mg of canagliflozin daily for six (6) months in addition to standard of care.
Sponsors
Collaborators: University of Michigan
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov