NCT05133050

Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants

Safety and Efficacy of Early Angiotensin-converting Enzyme Inhibition in Patients With Alport Syndrome Carrying Pathogenic Heterozygous COL4A3,COL4A4 or COL4A5 Mutations

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 510 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Alport syndrome (AS) is the second most common monogenic cause of end-stage renal failure (ESRF). AS is caused by variants in the COL4A3, COL4A4, and COL4A5 genes, which encode for the a3, a4, and a5 chains of type IV collagen. This trial is a prospective, randomized, controlled and multicenter trial. Mainly to assess the safety and efficacy of ramipril in Alport syndrome patients with variants of COL4A3/COL4A4/COL4A5.

Conditions

• Alport Syndrome

Interventions

Type	Name	Description
DRUG	Ramipril	We use ACEI: ramipril, in this prospective, randomized, controlled and multicenter clinical trial to access the safety and efficacy in Alport syndrome patients carried COL4A3/COL4A4/COL4A5 variants.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-31
• Completion: 2026-12-31
• First posted: 2021-11-24
• Last updated: 2021-11-24

Locations

1 site across 1 country: China