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Clinical Trial Details

Trial ID: L1291
Source ID: NCT06147232
Associated Drug: Sotagliflozin
Title: Prevention of Chronic Kidney Disease(CDK) Progression in Type 1 Diabetes With Long Term Use of Sodium-Glucose-coTransporter Inhibitors Avoiding Kidney hypOxia
Acronym: PLUTO
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Nephropathy|Diabetic Nephropathies|Diabetes Mellitus, Type 1|Albuminuria|Diabetic Complications Renal|Diabetic Complications Cardiovascular|Hypoxia
Interventions: DRUG: Sotagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change in dynamic R2*-weighted signal (BOLD) as an indirect measure of renal blood oxygenation, difference between change from 0 to 12 weeks after treatment with sotagliflozin compared to treatment with placebo, 0 to 12 weeks in both treatment arms, last measure 30 weeks after randomization. | Secondary: Change in renal perfusion (medullary and cortical), Measured with MRI by arterial spin labelling in mL/g/min, From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization|Change in renal artery flow, Renal artery flow measured by using phase contrast (PC) MRI. It is measured in mL/min., From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization|Change in renal oxygen consumption, Renal oxygen consumption measured by MRI with T2-relaxation-under-spin-tagging., From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization|Change in renal parenchymal triglyceride fraction, Renal parenchymal triglyceride fraction is measured by MRI spectroscopy, From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization|Change in renal fibrosis, Renal fibrosis is measured by MRI-derived apparent diffusion coefficient, From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization|Change in left ventricular ejection fraction, Left ventricular ejection fraction is assessed by MRI, From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization|Change in albuminuria, Urinary albumin-creatinine ratio (UACR) - morning void spot urine samples collected at home by participants., From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.|Change in levels of ketone bodies, Capillary blood ketones, possibly measured by continous ketone monitoring device, From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.|Change in plasma and urine inflammation- and fibrosis biomarkers, Measured from blood and urine samples using a commercially available panel from the company Olink. Includes 92 biomarkers., From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.|Change in endogenous erythropoietin, Analysis on blood samples at regional hospital laboratory., From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.|Change in pro brain natriuretic peptide, Analysis on blood samples at regional hospital laboratory., From 0 to 12 weeks in each treatment arm. Last measure 30 weeks after randomization.|Difference in Kidney Function after 12 weeks treatment with sotagliflozin vs placebo, Glomerular filtration rate. At Steno Diabetes Center Copenhagen this will be measured by plasma clearance of Tc-99m diethylene-triamine-pentaacetate., From 12 to 30 weeks after randomization | Other: Ethnicity, if African-Caribbean ethnicity is associated with any of the above secondary outcomes or baseline differences in cardio-renal disease markers/imaging measures, From baseline to 30 weeks.
Sponsor/Collaborators: Sponsor: Steno Diabetes Center Copenhagen | Collaborators: Juvenile Diabetes Research Foundation|King's College London|Glostrup University Hospital, Copenhagen|Guy's and St Thomas' NHS Foundation Trust
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 69
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2025-02
Completion Date: 2027-05
Results First Posted:
Last Update Posted: 2025-01-27
Locations: Steno Diabetes Center Copenhagen, Herlev, 2730, Denmark|Guy's and St Thomas NHS Trust, London, United Kingdom
URL: https://clinicaltrials.gov/show/NCT06147232