Effects of Dapagliflozin on Progression of Alport Syndrome

Active, not recruiting

• Conditions: Alport Syndrome
• Interventions: Drug: Dapagliflozin 10mg Tab

• Registration Number: NCT06226896
• Lead Sponsor: Nanjing University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dapagliflozin + RAS inhibitor	Dapagliflozin 10mg Tab	In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months.

Primary Outcome Measures

Name	Time	Method
Change of eGFR	24 months	The change of eGFR from baseline after 24 months of treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China