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This is a multicenter, randomized, placebo-controlled study to evaluate the effectiveness and safety of low-dose aspirin (50 mg/day) in renal and cardiac function protection in people with diabetic nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Experimental |
| |
| Comparator group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid | Drug | aspirin 50 mg/d to be taken after dinner (in nonfasting conditions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| decline of renal function | The aim of the study is to evaluate the decline of renal function, as assessed by absolute change in eGFR, calculated as the difference between eGFR at 3 years and baseline eGFR, in T2DM patients receiving low-dose aspirin (50 mg/d) or lacebo. | 3YEARS |
| Measure | Description | Time Frame |
|---|---|---|
| The rapid decline in renal function | The rapid decline in renal function, defined as a reduction of eGFR ≥5 mL/min at 1 year | 3YEARS |
| Change of renal function class | Change of renal function class (from G1 to G2, from G2 to G3a, and so on) at 3 years, dialysis, or transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Placebo | Drug | Placebo 50 mg/d to be taken after dinner (in nonfasting conditions) |
|
| 3YEARS |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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