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NCT06291155 · ClinicalTrials.gov registry record · Phase 4
Mechanism of SGLT2 Inhibition in the Kidney
A Phase 4 study of Type 2 Diabetes and Diabetic Kidney Disease, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06291155 is a Phase 4 study of Type 2 Diabetes and Diabetic Kidney Disease that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 20 participants, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06291155, a Phase 4 study of Type 2 Diabetes and Diabetic Kidney Disease, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG SGLT2 inhibitor
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-01-01 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06291155
The ClinicalTrials.gov registry entry for NCT06291155 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,103-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which SGLT2 inhibitor is the first listed.
NCT06291155 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT06291155 about?
NCT06291155 is a clinical study titled "Mechanism of SGLT2 Inhibition in the Kidney". 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 ...
What is the current status of trial NCT06291155?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2024-01-01. Estimated completion is 2028-06-30.
What conditions does trial NCT06291155 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Diabetic Kidney Disease.
What interventions are being tested in trial NCT06291155?
The interventions under investigation include: SGLT2 inhibitor (DRUG).
Who is sponsoring clinical trial NCT06291155?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06291155 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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