A Study to Evaluate Setanaxib in Patients With Alport Syndrome

Status Recruiting

Clinical Trial Summary

The purpose of the study is to learn about the safety and tolerability of setanaxib in subjects with Alport syndrome, when added to their standard of care treatment. The study will assess how safe setanaxib is when compared to placebo. Study participants will be asked if they are experiencing any side effects at each study visit. In addition, tests in blood, urine and other examinations will be used to look at the safety of setanaxib. The study will also measure how well setanaxib works in comparison to a placebo, by measuring urine protein and certain markers in the blood and urine. The concentration of setanaxib in the blood will also be measured throughout the course of the study. Setanaxib is planned for use together with the current standard of care to hopefully provide additional therapeutic benefits by preserving kidney function. The study will be conducted at multiple research sites in the UK, Spain, and Czech Republic. Eligible participants will be randomly assigned to receive either setanaxib or placebo. Setanaxib dose level will depend on age and all participants will receive their standard of care in addition to setanaxib or placebo. The study consists of a Screening period of up to 4 weeks, a 24-week Treatment period and a 4- week Follow-up period.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06274489
Study type	Interventional
Source	Calliditas Therapeutics AB
Contact	Maria Norling
Phone	+46 76 496 2566
Email	maria.norling@calliditas.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	November 27, 2023
Completion date	January 27, 2025

View Details

See also
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