Clinical trial NCT06528405: The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
Official title: The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Kidney Injury
Keywords: sodium-glucose cotransporter 2 inhibitor
acute kidney disease
albuminuria
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: China Medical University Hospital
First posted: 2024-07-30
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and \< 80 years
* Diagnosed with acute kidney disease
* Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73m²
* Albuminuria \> 100 mg/g or proteinuria \> 300 mg/g (adjusted by urine creatinine)
* Diagnosed with diabetes or chronic kidney disease

Exclusion Criteria:

* Received sodium-glucose cotransporter 2 (SGLT2) inhibitors within 28 days prior to enrollment
* Patients with type 1 diabetes
* Receiving aggressive immunosuppressive therapy for glomerulonephritis
* Obstructive nephropathy
* Polycystic kidney disease
* Malignancy within 3 months or expected to undergo aggressive treatment such as chemotherapy, radiation therapy, immunotherapy, or targeted therapy in the future
* Pregnant or breastfeeding women
* Clinically assessed as not having recovered from acute kidney injury
* Clinically assessed as at high risk for complications related to SGLT2 inhibitors

Primary outcomes:
measure: Albuminuria
timeFrame: Day 28 and Day 90
measure: Discontinuation of SGLT2i
timeFrame: Day 0 to Day 90
Secondary outcomes:
measure: eGFR
timeFrame: Day 28 to Day 84 or Day 28 to Day 168
measure: Major adverse kidney events
timeFrame: Day 0 to Day 180
measure: Major adverse cardiovascular events
timeFrame: Day 0 to Day 180
measure: Death
timeFrame: Day 0 to Day 180
measure: Amputation
timeFrame: Day 0 to Day 180
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: