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NCT05713851: DAKI-CKD

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

Status unknown Phase 2, PHASE3 Last updated 5 March 2024
What this trial tests

Phase 2, PHASE3 trial testing Dapagliflozin in AKI - Acute Kidney Injury in 100 participants. Status unknown.

Timeline
1 January 2023
Primary endpoint
1 December 2024
1 January 2025

Quick facts

Lead sponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment100
Start date1 January 2023
Primary completion1 December 2024
Estimated completion1 January 2025
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran — full company profile →

Who can join

Adults 18 to 75, any sex, with AKI - Acute Kidney Injury or Biomarkers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Transient inhibition of sodium-glucose cotransporter 2 after ischemia/reperfusion injury ameliorates chronic kidney disease.
    Martínez-Rojas MÁ, Balcázar H, González-Soria I, González-Rivera JM, et al · · 2024 · cited 8× · PMID 38516890 · DOI 10.1172/jci.insight.173675
  2. SGLT2i treatment during AKI and its association with major adverse kidney events.
    Alcantar-Vallin L, Zaragoza JJ, Díaz-Villavicencio B, Hernandez-Morales K, et al · · 2024 · cited 3× · PMID 38933678 · DOI 10.3389/fphar.2024.1356991
  3. Transition from acute kidney injury to chronic kidney disease: molecular mechanisms and therapeutic interventions.
    Huang X, Wang M, Yu B, Ren P, et al · · 2026 · PMID 42105162 · DOI 10.1186/s43556-026-00462-z

Verify or expand the search:

Other trials of Dapagliflozin

Trials testing the same drug.

Other recruiting trials for AKI - Acute Kidney Injury

Currently open trials in the same condition.

Other Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing