Effects of Dapagliflozin on Progression of Alport Syndrome

NCT06226896 | Active Not Recruiting

• 1 other identifier: 2023DZKY-094
• Study Type: observational
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Alport Syndrome

Outcome Measures

Primary Outcomes (1)

• Change of eGFR

  The change of eGFR from baseline after 24 months of treatment

  24 months

Secondary Outcomes (2)

• Change of proteinuria

  24 months

• Progression of kidney disease

  24 months

Other Outcomes (2)

• Change of eGFR in different subgroups

  24 months

• Change of proteinuria in different subgroups

  24 months

Study Arms (2)

Dapagliflozin + RAS inhibitor

In addition to ACEI/ARB treatment, patients will receive dapagliflozin 10mg once daily for 24 months.

Drug: Dapagliflozin 10mg Tab

RAS inhibitor only

Patients will continue ACEI/ARB treatment for 24 months.

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10mg daily plus RAS inhibitor

Also known as: Dapagliflozin

Dapagliflozin + RAS inhibitor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Alport syndrome who are at risk for kidney disease progression

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Jinling Hospital

Nanjing, Jiangsu, 210016, China

Location

MeSH Terms

Conditions

Nephritis, Hereditary

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yu An, MD

  National Clinical Research Center of Kidney Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: November 15, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

CN (1)