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Recently, a series of large clinical trials have confirmed the cardio-renal protective effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors. but few patients with hereditary nephritis were included in these studies. This study is to evaluate the effects of dapagliflozin on slowing kidney disease progression in patients with Alport syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin + RAS inhibitor | In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months. |
| |
| RAS inhibitor only | Patients will continue ACEI/ARB treatment for 24 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10mg Tab | Drug | Dapagliflozin 10mg daily plus RAS inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of eGFR | The change of eGFR from baseline after 24 months of treatment | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of proteinuria | The change of proteinuria from baseline after 24 months of treatment | 24 months |
| Progression of kidney disease | The incidence of doubling of serum creatinine, a sustained ≥40% eGFR decline from baseline, or end-stage kidney disease after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change of eGFR in different subgroups | The change of eGFR from baseline in patients with different phenotype -genotype after treatment | 24 months |
| Change of proteinuria in different subgroups | The change of proteinuria from baseline in patients with different phenotype -genotype after treatment |
Inclusion Criteria:
Exclusion Criteria:
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Patients with Alport syndrome who are at risk for kidney disease progression
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| Name | Affiliation | Role |
|---|---|---|
| Yu An, MD | National Clinical Research Center of Kidney Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Nanjing | Jiangsu | 210016 | China |
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| ID | Term |
|---|---|
| D009394 | Nephritis, Hereditary |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| 24 months |
| 24 months |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |