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NCT06291155

Mechanism of SGLT2 Inhibition in the Kidney

Recruiting now Phase 4 Last updated 3 October 2024
What this trial tests

Phase 4 trial testing SGLT2 inhibitor in Type 2 Diabetes in 20 participants. Currently enrolling.

Timeline
1 January 2024
Primary endpoint
31 December 2026
30 June 2028

Quick facts

Lead sponsorUniversity of Michigan
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment20
Start date1 January 2024
Primary completion31 December 2026
Estimated completion30 June 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Michigan

Who can join

Adults 18 to 80, any sex, with Type 2 Diabetes or Diabetic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of SGLT2 inhibitor

Trials testing the same drug.

Other recruiting trials for Type 2 Diabetes

Currently open trials in the same condition.

Other University of Michigan trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06291155.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing