Dapagliflozin in Non-diabetic Stage IV CKD

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT04794517
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    Dapagliflozin 10 mg/die will be administered orally for six-weeks.
  • Placebo — OTHER
    Placebo one tablet/die will be administered orally for six-weeks.

Study Details

This is a phase 2b, prospective, randomized, cross-over, double-blind, placebo-controlled trial primarily aimed at assessing whether the SGLT2 inhibitor dapagliflozin ameliorates hyperfiltration and reduces proteinuria as compared to placebo in patients with non-diabetic CKD, with particular focus on those at highest risk of progression to end stage kidney disease (ESKD) because of severe renal insufficiency (Stage IV CKD) and proteinuria (\>0.5 g/24 hours). The study will also evaluate renal and systemic mechanisms mediating treatment effects on GFR and will explore biochemical factors possibly mediating these effects.

Key Dates

Start date
Nov 8, 2021
Status verified
May 2024
Primary completion
May 7, 2024
Completion
May 7, 2024

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: IMP
    Dapagliflozin 10 mg/die will be administered orally for six-weeks.
  • Placebo Comparator: Placebo
    Placebo, one tablet/die will be administered orally for six-weeks.

Primary Outcome Measure

Glomerular Filtration rate (GFR) [ Time Frame: Changes from baseline and day 1, 8, 42,84, 92,126 and 140. ]

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