The Phase 3 trial (NCT05468203) investigating dapagliflozin for Acute Kidney Injury was terminated on 2025-07-18 after reaching primary completion. The study, titled "PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care," had enrolled 51 participants.
Background
Dapagliflozin is a medication used to treat patients with diabetes, heart disease, and chronic kidney disease. The trial aimed to investigate its potential role in Acute Kidney Injury (AKI). AKI is a serious condition characterized by unsafe levels of fluid and waste products accumulating in the body. It often necessitates treatment with renal replacement therapy, such as dialysis, and can progress to a chronic condition if left untreated.
Trial design
The PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care study (NCT05468203) was a Phase 3, randomized, placebo-controlled trial. It enrolled 51 participants diagnosed with Acute Kidney Injury. Participants were assigned to receive either dapagliflozin 10mg tab or a placebo.
What this means
The termination of this Phase 3 trial for dapagliflozin in Acute Kidney Injury indicates that further development in this specific indication, under this trial design, has ceased. While the trial reached primary completion, the overall status of 'Terminated' suggests that the study will not proceed as originally planned to full completion or data analysis for its primary outcomes.
Source
The information regarding the primary completion and termination of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT05468203, titled "PREVENTion With Sglt-2 Inhibition of Acute Kidney Injury in Intensive Care," was updated with a primary completion date of 2025-07-18 on clinicaltrials.gov.