| Trial ID: | L2609 |
| Source ID: | NCT05507892
|
| Associated Drug: |
Canagliflozin
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| Title: |
Renal Mechanism of SGLT2 Inhibition
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| Acronym: |
|
| Status: |
UNKNOWN
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Type 2 Diabetes|Diabetic Kidney Disease
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| Interventions: |
DRUG: canagliflozin|DRUG: Aminohippurate Sodium Inj 20%
|
| Outcome Measures: |
Primary: Glomerular basement membrane (GBM) width and mesangial expansion, measured by morphometric examination of kidney tissue, 6 months|Kidney Transcript Changes, Molecular changes measured by change in transcripts as assessed by single-cell RNA sequencing of kidney biopsy specimens, 6 months | Secondary: Cortical R2, Measured by Blood Oxygen Level Dependent (BOLD) MRI; Participants will be scanned in a supine position with a 3T MRI scanner. Spine array and body array receiver coils will be used to maximize image uniformity. Following initial localizer scans, coronal Sec T2-weighted MR images will be obtained to delineate cortical kidney regions. The image acquisition will be respiratory-gated to ensure accurate image co-registration with the respiratory-gated diffusion acquisitions., 6 months|Medullary R2, Measured by Blood Oxygen Level Dependent (BOLD) MRI; Participants will be scanned in a supine position with a 3T MRI scanner. Spine array and body array receiver coils will be used to maximize image uniformity. Following initial localizer scans, coronal Sec T2-weighted MR images will be obtained to delineate medullary kidney regions. The image acquisition will be respiratory-gated to ensure accurate image co-registration with the respiratory-gated diffusion acquisitions., 6 months|Renal Perfusion, Measured by Arterial Spin Labeling (ASL), 6 months|Glomerular Filtration Rate (GFR), Measured by iohexol clearance; An intravenous (IV) line will be placed, and participants will be asked to empty their bladders. Spot plasma and urine samples will be collected prior to iohexol infusion. Iohexol will be administered through bolus IV injection (36 mg/kg/dose), followed by infusion (15mg/min over 180 min.) An equilibration period of 120 min was used and blood collections for iohexol plasma disappearance were drawn at +120, +150, +180 min., 3 Hours|Renal Plasma Flow (RPF), Measured by para-aminohippurate (PAH) clearance; An intravenous (IV) line will be placed, and participants will be asked to empty their bladders. Spot plasma and urine samples will be collected prior to PAH infusion. PAH (2 g/10 mL, prepared by Basic Pharma, with a dose of (16 mg/kg or 12 mg/kg depending on eGFR) will be given slowly over 5 min followed by a continuous infusion of 8 mL of PAH and 42 mL of normal saline at a rate or 7.2 mg/kg/ hr or 5.0 mg/kg/hr for 2 h, depending on eGFR. After an equilibration period, blood will be drawn at 90, 120, and 150 min, and RPF will be calculated as PAH clearance divided by the estimated extraction ratio of PAH, which varies by the level of GFR., 2.5 Hours
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| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver | Collaborators: Boston Medical Center|University of Michigan|Brigham and Women's Hospital
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
40
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2022-10-10
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| Completion Date: |
2024-07-15
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| Results First Posted: |
|
| Last Update Posted: |
2022-11-03
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| Locations: |
University of Colorado Denver, Aurora, Colorado, 80045, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|Boston Medical Center, Boston, Massachusetts, 02118, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05507892
|
