Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Chang Gung Memorial Hospital | OTHER |
| China Medical University Hospital | OTHER |
| National Cheng-Kung University Hospital | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT2i | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dapagliflozin | Drug | Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albuminuria | The changes in albuminuria compared with baseline | Day 28 and Day 90 |
| Discontinuation of SGLT2i | Development of adverse events leading to discontinuation of SGLT2i | Day 0 to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR | The changes in eGFR | Day 28 to Day 84 or Day 28 to Day 168 |
| Major adverse kidney events | eGFR reduction >50%, dialysis, or death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Szu-Yu Pan, MD, PhD | Contact | +886-23123456 | 41845 | szuyupan@ntu.edu.tw |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other anti-diabetic drug or no anti-diabetic drug | Other | 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. |
|
| empagliflozin | Drug | Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period. |
|
| canagliflozin | Drug | Sodium-glucose cotransporter 2 inhibitor for 90 days during the acute kidney disease period. |
|
| Day 0 to Day 180 |
| Major adverse cardiovascular events | hospitalization due to heart failure or death | Day 0 to Day 180 |
| Death | All-cause mortality | Day 0 to Day 180 |
| Amputation | Any amputation event | Day 0 to Day 180 |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
| D000068896 | Canagliflozin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
Not provided
Not provided