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
Status	Clinical Trial	Phase
Terminated	`NCT01602835` - Human Urine Sample Collection for Alport Nephropathy Biomarker Studies	N/A
Completed	`NCT01696253` - Multi-center Controlled Clinical Trials in Alport Syndrome-A Feasibility Study
Recruiting	`NCT00481130` - Alport Syndrome Treatments and Outcomes Registry
Recruiting	`NCT05687474` - Baby Detect : Genomic Newborn Screening
Recruiting	`NCT06065852` - National Registry of Rare Kidney Diseases
Recruiting	`NCT05448755` - A Study of ELX-02 in Patients With Alport Syndrome	Phase 2
Terminated	`NCT02855268` - Study of Lademirsen (SAR339375) in Patients With Alport Syndrome	Phase 2
Recruiting	`NCT06226896` - Effects of Dapagliflozin on Progression of Alport Syndrome
Recruiting	`NCT05927467` - Eurbio-Alport (RaDiCo Cohort) (RaDiCo Eurbio-Alport)
Terminated	`NCT03749447` - An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)	Phase 3
Completed	`NCT03019185` - A Phase 2/3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients With Alport Syndrome - CARDINAL	Phase 2/Phase 3
Recruiting	`NCT06425055` - Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1)	Phase 2
Completed	`NCT01705132` - Urinary Biomarkers of the Progression of Alport Kidney Disease	N/A
Recruiting	`NCT05267262` - Study to Evaluate R3R01 in Patients With Alport Syndrome and Patients With Focal Segmental Glomerulosclerosis	Phase 2
Completed	`NCT00622544` - A Prospective Study of Microalbuminuria in Untreated Boys With Alport Syndrome
Recruiting	`NCT02378805` - European Alport Therapy Registry - European Initiative Towards Delaying Renal Failure in Alport Syndrome
Not yet recruiting	`NCT05655728` - Treatment With Metformin in Chinese Children With Alport Syndrome	Phase 4
Completed	`NCT00309257` - Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome	Phase 2
Not yet recruiting	`NCT05133050` - Safety and Efficacy of ACEI in Alport Syndrome Patients With COL4A3/COL4A4/COL4A5 Variants	N/A
Recruiting	`NCT04947813` - Genotype-Phenotype Correlations in Patients With Alport Syndrome