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Clinical Trial Details

Trial ID: L1055
Source ID: NCT05998837
Associated Drug: Dapagliflozin 10mg Tab
Title: GLUcose Transport and REnalPROtection in Chronic Kidney Disease
Acronym: GLUTREPRO
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Diabetes Mellitus, Type 2|Hypertension
Interventions: DRUG: Dapagliflozin 10mg Tab|DRUG: Placebo
Outcome Measures: Primary: Urinary proximal tubule cells changes in protein expression of inflammatory genes such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFβ, SMAD 2,3 and MAPK pathways., baseline and every 3 months up to 18 month|Urinary proximal tubule cells changes in genes such as type IV collagen fibronectin, TGF-β, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A, baseline and every 3 months up to 18 month|Biopsy changes in the expression and location of senescence markers by immunohistochemistry, In the first six patients with T2DM, proteinuria \> 1 g/day and biopsy proven diabetic kidney disese allocated to the treatment with dapagliflozin, we will investigate the following changes in expression and location of p16inkA, SA-beta-galactosidase, TNF receptor 1, EMF cadherin NF-kB., Baseline and after 6 month | Secondary: Changes in BOLD MRI, Changes in global and segmental renal oxygenation estimated by BOLD MRI (changes in R2\* value defined as 1/T2\*) at 12 and 24 weeks, Baseline and after 3 month|Urinary markers of interstitial fibrosis, Changes in urinary markers of a proxy of interstitial fibrosis in patients with CKD (Mir 20), Baseline and every 3 months up to 18 month|Changes in urinary albumin excretion, Changes in urinary albumin excretion, Baseline and every 3 months up to 18 month|Changes in eGFR, decrease of eGFR ml/min \> 30%, Baseline and every 3 months up to 18 month|Outcomes of blood presssure control, changes in blood pressure values and in the need of antihypertensive drugs, Baseline and every 6 months up to 18 month
Sponsor/Collaborators: Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | Collaborators: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 34
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2021-04-13
Completion Date: 2024-09-30
Results First Posted:
Last Update Posted: 2025-03-28
Locations: IRCCS Ospedale Policlinico San Martino, Genova, GE, 16132, Italy
URL: https://clinicaltrials.gov/show/NCT05998837