Alport Syndrome
Conditions
Brief summary
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.
Interventions
DRUGDapagliflozin 10mg Tab
Dapagliflozin 10mg daily plus RAS inhibitor
Sponsors
Nanjing University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Histologic or genetic confirmation of Alport syndrome; * eGFR ≥ 30 ml/min/1.72m2; * Proteinuria \> 0.5 g/24 h; * Use of an ACE inhibitor or ARB, dose stable for more than 4 weeks;
Exclusion criteria
* Concurrence of other types of kidney disease; * type 1 or type 2 diabetes; * use of other types of sodium-glucose cotransporter 2 inhibitors within the month prior to enrollment, or prior allergy to such drugs; * ACEI combined with ARB, or direct renin inhibitors, aldosterone receptor antagonists; * Uncontrolled hypertension (blood pressure greater than 160/90 mmHg during screening); * Patients undergoing renal transplantation or maintenance dialysis treatment; * Coexist with other serious and/or unstable diseases, such as serious cardiovascular diseases, respiratory diseases, liver diseases or neuropsychiatric diseases; * Patients who are participating in clinical trials of other drugs; * Pregnant or lactating women, or patients who do not want to receive contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of eGFR | 24 months | The change of eGFR from baseline after 24 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of proteinuria | 24 months | The change of proteinuria from baseline after 24 months of treatment |
| Progression of kidney disease | 24 months | The incidence of doubling of serum creatinine, a sustained ≥40% eGFR decline from baseline, or end-stage kidney disease after treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change of eGFR in different subgroups | 24 months | The change of eGFR from baseline in patients with different phenotype -genotype after treatment |
| Change of proteinuria in different subgroups | 24 months | The change of proteinuria from baseline in patients with different phenotype -genotype after treatment |
Countries
China
Outcome results
None listed