NCT05655728

Treatment With Metformin in Chinese Children With Alport Syndrome

Efficacy and Safety of Metformin in Alport Syndrome: A Randomized, Double-blind, Placebo-controlled Study in China

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center, prospective, double-blind randomized placebo-controlled trial will evaluate the efficacy and safety of metformin in Chinese children with Alport syndrome who have received (and continue to receive)) ACEi/ARB.

Conditions

• Alport Syndrome
• Metformin

Interventions

Type	Name	Description
DRUG	Metformin	The participants will receive treatment of metformin (initial dose of 500 mg/day, within 2 weeks reaching the maximum tolerated dose \[maximum: 1500 mg/day\]).
OTHER	Placebo	The participants will receive treatment of placebo.

Timeline

• Start date: 2023-01-03
• Primary completion: 2025-01-31
• Completion: 2025-04-20
• First posted: 2022-12-19
• Last updated: 2022-12-19