RecruitingPhase 2Phase 3NCT05713851

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

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


Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Enrollment

100 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether dapagliflozin — a diabetes drug that also protects the kidneys — can prevent acute kidney injury (sudden kidney damage) from permanently becoming chronic kidney disease in hospitalized patients. **You may be eligible if...** - You are an adult (over 18) admitted to hospital with severe acute kidney injury (AKI stage 3) diagnosed within the last 24 hours - Your kidney injury is consistent with damage to the kidney tubules from low blood flow or toxic exposure **You may NOT be eligible if...** - You already have advanced chronic kidney disease, a kidney transplant, or a blockage in your urinary tract - You are on high doses of vasopressors (blood pressure-supporting medications) - You have severely low blood oxygen levels - You have type 1 diabetes - You have not eaten for more than 48 hours - You are pregnant or breastfeeding - You have a cancer diagnosis with a life expectancy under 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDapagliflozin

dapagliflozin is given for 21 days vs standard of care


Locations(1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05713851


Related Trials