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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Collaborators: Miguel Ángel Martínez Rojas; Noemi del Toro Cisneros; Olynka Vega Vega
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

• Adults (aged >18 years) with AKI 3 diagnosis for less than 24 h (KDIGO classification, creatinine level or urine output criteria), hospitalized in general admission floor and/or intensive care unit. AKI diagnosis must be compatible with the diagnosis of acute tubular necrosis in a context of ischemic or toxic aggression.

Exclusion Criteria:

• CKD Stage 3b (KDIGO) or more, renal transplant, urinary tract obstruction, thrombotic microangiopathy, acute glomerulopathy, cardiac arrest without awakening, oncological diagnosis with a life expectancy of less than 5 years, use of norephinephrine >0.30 mcg/kg/min for 6 h or more, use of two vasopressors, PaO2/FiO2 ratio <150, Type 1 DM, fasting for more than 48 h, previous inclusion in other study, pregnant or breastfeeding woman.