GLUcose Transport and REnalPROtection in Chronic Kidney Disease

Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study ID
NCT05998837
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject. Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide
  • Placebo — DRUG
    Placebo will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject. Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide

Study Details

This is a single-center, double blind, randomized, parallel-arms study designed to investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of kidney senescence, inflammation and tubulointerstitial damage compared to placebo. These mechanisms of renal damage will be investigated in proximal tubular epithelial cells (PTECs) isolated from urine from patients with CKD with or without T2DM and in renal biopsy specimens in a subgroup of patients with diabetic kidney disease.

Key Dates

Start date
Apr 13, 2021
Status verified
Feb 2025
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Type 2 Diabetes Dapagliflozin 10 mg
    Patients with Type 2 Diabetes allocated to Dapagliflozin 10 mg
  • Placebo Comparator: Type 2 Diabetes Placebo
    Patients with Type 2 Diabetes allocated to Placebo
  • Active Comparator: Without Diabetes Dapagliflozin 10 mg
    Patients without Type 2 Diabetes allocated to Dapagliflozin 10 mg
  • Placebo Comparator: Without Diabetes Placebo
    Patients without Type 2 Diabetes allocated to Placebo

Primary Outcome Measure

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. [ Time Frame: baseline and every 3 months up to 18 month ]

Related Studies