Using dapagliflozin to prevent kidney injury from worsening
Potential Use of Dapaglifozin to Avoid Acute Kindey Injury (AKI) to Chronic Kidney Disease (CKD) Transition: DAKI-CKD Study
This study tests if adding dapagliflozin to regular treatment can help hospitalized patients with severe acute kidney injury avoid developing chronic kidney disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Academic / other |
| Locations | 1 site (Mexico City) |
| Trial ID | NCT05713851 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of dapagliflozin, combined with standard medical treatment, in hospitalized patients diagnosed with severe acute kidney injury (AKI). The study aims to determine if this intervention can reduce the transition from AKI to chronic kidney disease (CKD) over an 18-month follow-up period. A total of 100 patients will be randomly assigned to receive either dapagliflozin or standard care for 21 days. The trial is designed as a randomized, single-center, open-label study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been hospitalized with a diagnosis of severe AKI for less than 24 hours.
Not a fit: Patients with pre-existing chronic kidney disease, certain acute conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing chronic kidney disease in patients who have experienced acute kidney injury.
How similar studies have performed: Other studies have explored similar therapeutic strategies, but this specific approach using dapagliflozin in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán — Mexico City, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.