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Mechanism of SGLT2 Inhibition in the Kidney

StatusRecruiting
PhasePhase 4
Started2024-01-01
View on ClinicalTrials.gov ↗

Amendment history

2026-06-09
minor
Study Status, Sponsor/Collaborators, Study Description, Contacts/Locations v2
Primary completion date2026-12-31→2027-12-31
Completion date2028-06-30→2028-02-28
Study description+111 characters
[...] rial until death or development of end-stage kidney disease. Participants will be followed for potential adverse events for an additional two months post six-month biopsy.
Study sitescontacts updated at 1 of 1 site
Collaborators2 to 1 entries
Renal Pre-Competitive Consortium (RPC3)
2024-10-01
minor
Study Identification, Study Status, Contacts/Locations v1
Study sitescontacts updated at 1 of 1 site
Study title+8 characters
Renal Mechanism of SGLT2 Inhibition in the Kidney
2024-02-26
minor
Original filing
4,247 trials monitored
See 176 trials at risk
2,082 trials monitored
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The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years. Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study: Consent and Screening: * Laboratory tests to determine baseline health * Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys Month 0: * Study entry kidney MRI (day 0) * Study entry kidney biopsy (within 30 days of MRI) * Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supply Month 3: * Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication * Review of systems Month 6: * Follow-up kidney MRI * Follow-up kidney biopsy Study participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs). Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples.
Trial Details
NCT Number NCT06291155
Lead Sponsor University of Michigan
Collaborators: University of Colorado, Denver
Conditions Type 2 Diabetes, Diabetic Kidney Disease
Enrollment 20 participants
Start Date 2024-01-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-11