The Efficacy and Safety of Sodium-glucose Cotransporter 2 Inhibitors in Patients With Acute Kidney Disease

Обзор

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.

Вмешательства

• Препарат dapagliflozin
  Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
• Другое Other anti-diabetic drug or no anti-diabetic drug
  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.
• Препарат empagliflozin
  Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.
• Препарат canagliflozin
  Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period.

Первичные конечные точки

• Albuminuria [Срок оценки: Day 28 and Day 90]
• Discontinuation of SGLT2i [Срок оценки: Day 0 to Day 90]

Вторичные конечные точки (5)

• eGFR [Срок оценки: Day 28 to Day 84 or Day 28 to Day 168]
• Major adverse kidney events [Срок оценки: Day 0 to Day 180]
• Major adverse cardiovascular events [Срок оценки: Day 0 to Day 180]
• Death [Срок оценки: Day 0 to Day 180]
• Amputation [Срок оценки: Day 0 to Day 180]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT06528405 · 202404095MINE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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