Effects of Dapagliflozin on Progression of Alport Syndrome

Alport Syndrome Clinical Trial

Official title:

Effects of Dapagliflozin on Progression of Alport Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226896
• Other study ID #: 2023DZKY-094
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: Nanjing University School of Medicine
• Contact: Qiong Wu
• Phone: +8680863234
• Email: wuqiong80863234[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alport Syndrome
• Nephritis, Hereditary
• Syndrome

Intervention

Drug:
• Dapagliflozin 10mg Tab
Dapagliflozin 10mg daily plus RAS inhibitor

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The incidence of doubling of serum creatinine, a sustained =40% eGFR decline from baseline, or end-stage kidney disease after treatment		24 months
Other	Changes of eGFR and proteinuria from baseline in patients with different phenotype -genotype after treatment		24 months
Primary	The change of eGFR from baseline after 24 months of treatment		24 months
Secondary	The change of proteinuria from baseline after 24 months of treatment		24 months