Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study.
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Collaborators:
Miguel Ángel Martínez Rojas Noemi del Toro Cisneros Olynka Vega Vega