National Taiwan University Hospital
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT06528405
Acute kidney disease (AKD) happens between 7 and 90 days after an initial kidney injury (AKI). This period is crucial because it can determine whether the condition worsens into chronic kidney disease (CKD). Despite knowing this, there is no proven treatment to improve outcomes for people with AKD.
Recent studies have shown that drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors can slow down the worsening of chronic kidney disease, help with heart failure, and reduce the risk of death. Now, researchers are looking into whether these drugs can also help prevent acute kidney injury (AKI) and improve outcomes for AKD patients.
Our project will explore the use of SGLT2 inhibitors in patients with AKD, with the belief that these drugs can safely reduce the amount of protein (albumin) in the urine and improve kidney health. To address this, investigators plan to conduct a large, multicenter study in Taiwan. This study will be randomized and placebo-controlled, meaning some patients will receive the SGLT2 inhibitors while others will receive a placebo (a harmless, inactive substance). Investigators will include AKD patients with and without diabetes, focusing on reducing the protein in their urine and monitoring for any serious side effects.
The goal of this trial is to provide strong evidence on whether SGLT2 inhibitors can be an effective treatment for AKD. If successful, this could offer a new strategy to prevent the progression from AKI to CKD and improve the health and outcomes of patients with kidney disease.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Taipei, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Other anti-diabetic drug or no anti-diabetic drug for 90 days during the acute kidney disease period.
Other anti-diabetic drug includes metformin, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitor, insulin, α-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 receptor agonist.
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
Time frame: Day 28 and Day 90
The changes in albuminuria compared with baseline
Time frame: Day 0 to Day 90
Development of adverse events leading to discontinuation of SGLT2i
Time frame: Day 28 to Day 84 or Day 28 to Day 168
The changes in eGFR
Time frame: Day 0 to Day 180
eGFR reduction >50%, dialysis, or death
Time frame: Day 0 to Day 180
hospitalization due to heart failure or death
Time frame: Day 0 to Day 180
All-cause mortality
Time frame: Day 0 to Day 180
Any amputation event
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Acronym: ESS-AKD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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