Effects of Dapagliflozin on Progression of Alport Syndrome

Nanjing University School of Medicine

Status

Active, not recruiting

Conditions

Alport Syndrome

Treatments

Drug: Dapagliflozin 10mg Tab

Study type

Observational

Funder types

Other

Identifiers

NCT06226896

2023DZKY-094

Details and patient eligibility

About

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.

Enrollment

222 patients

Sex

All

Volunteers

No Healthy Volunteers

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.