Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study ID
NCT05713851
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • AKI - Acute Kidney Injury
  • Biomarkers
  • CKD
  • Transition to CKD

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin — DRUG
    dapagliflozin is given for 21 days vs standard of care

Study Details

Justification: Studies in recent years have shown that suffering an episode of acute kidney injury (AKI) is an independent risk factor for developing chronic kidney disease (CKD), which is associated with cardiovascular complications, increases medical care costs, and decreases survival. These AKI to ERC transition cases add to the growing number of CKD cases already being seen globally. It is for them that in recent years therapeutic strategies have been sought to reduce or stop this process of transition from AKI to CKD. Objective: To evaluate the efficacy and safety of the use of dapagliflozin plus standard medical treatment (TMS), compared with only TMS for 21 days, in hospitalized patients with a diagnosis of severe AKI (KDIGO 3) in reducing the incidence of CKD to 18 months of follow-up. Design: Randomized, single center, open study. 100 hospitalized patients with a diagnosis of AKI KDIGO 3, without previous CKD, will be randomized to receive 10 mg of dapagliflozin every 24 h for 21 days + TMS or only TMS. During their follow-up, baseline blood and urine samples will be taken and at 3, 6, 12 and 18 months. At 18 months, the development of CKD will be assessed using the KDIGO clinical criteria and with the determination of urinary biomarkers (Serpina A3, HSP72, KIM 1 and NGAL).

Key Dates

Start date
Jan 1, 2023
Status verified
Mar 2024
Primary completion
Dec 1, 2024
Completion
Jan 1, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapaglifozin group
    Dapagliflozin 10 mg, will be administered orally or by nasogastric tube every 24 h for 21 days.
  • Placebo Comparator: Standard of care
    Without receiving any of the interventional drugs.

Primary Outcome Measure

The primary outcome will be the mean change in urinary Serpin A3 (uSerpinA3) levels 18 months after randomization of the patients. [ Time Frame: 18 months ]

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