NCT04937907

Study of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)

Efficacy and Safety of Hydroxychloroquine in Patients With X-linked Alport Syndrome in China (CHXLAS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Shanghai Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients.

Detailed description

This Phase 2 randomized controlled trial will study the safety, tolerability, and efficacy of Hydroxychloroquine in qualified patients with Alport syndrome. The trial will be open-label, randomized, controlled and will enroll up to 50 patients. Patients in the Phase 2 cohort will be randomized 1:1 to either Hydroxychloroquine Cohort or Comparator Cohort. All patients in the study will follow the same visit and assessment schedule. Following randomization on Day 1, patients will be scheduled to be assessed during treatment at Weeks 4, 12, and 24. Patients will not receive study drug during a 24-week withdrawal period between Weeks 25 and 48. Patients will also be scheduled to be assessed at an in person follow up visit at Week 36, and 48.

Conditions

• Alport Syndrome, X-Linked

Interventions

Type	Name	Description
DRUG	Hydroxychloroquine Sulfate 100 milligram (mg) Tab	Patients administered HCQ by oral at a dose of 6.5mg per kilogram twice a day at least 6 months.
DRUG	Benazepril hydrochloride 10 milligram (mg) Tab	Patients administered Benazepril by oral at a dose of 5mg or 10mg once a day at least 6 months.

Timeline

• Start date: 2021-09-08
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-06-24
• Last updated: 2026-03-02

Locations

1 site across 1 country: China