Effects of Dapagliflozin on Progression of Alport Syndrome (NCT06226896) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Dapagliflozin on Progression of Alport Syndrome
China222 participantsStarted 2023-11-15
Plain-language 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.
Who can participate
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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.