protocolSection identificationModule nctId: NCT06274489, orgStudyIdInfo id: GSN000500, briefTitle: A Study to Evaluate Setanaxib in Patients With Alport Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-27, primaryCompletionDateStruct date: 2025-01-27, completionDateStruct date: 2025-01-27, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Calliditas Therapeutics AB, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Alport Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Setanaxib, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percentage of patients with Serious Adverse Events (SAEs), primaryOutcomes measure: Percentage of patients with treatment-emergent Adverse Events of Special Interest (AESIs), secondaryOutcomes measure: The ratio of urine protein to creatinine ratio (UPCR) analysed in 24-hour urine sample, secondaryOutcomes measure: Percentage of patients with a 25% reduction in UPCR analysed in 24-hour urine sample, secondaryOutcomes measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the area under the concentration-time curve over 24 hours at steady state (AUC0-24-ss), secondaryOutcomes measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the minimum plasma concentration at steady state (Cmin-ss), secondaryOutcomes measure: Pre-dose and post-dose plasma concentrations of setanaxib and GKT138184 measured as the maximum plasma concentration at steady state (Cmax-ss), otherOutcomes measure: Percentage of patients with clinically significant changes in heart rate, otherOutcomes measure: Percentage of patients with clinically significant changes blood pressure, otherOutcomes measure: Percentage of patients with clinically significant changes in 12-lead electrocardiogram (ECG), otherOutcomes measure: Percentage of patients with clinically significant changes in physical examination, otherOutcomes measure: Percentage of patients with clinically significant changes in hematology, serum chemistry, urinalysis, and thyroid function, otherOutcomes measure: Percentage of patients with clinically significant changes in hearing audiometric testing (bone- and air-conduction), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Fakultni Nemocnice Hradec Kralove, status: RECRUITING, city: Hradec Králové, country: Czechia, contacts name: Roman Safranek, role: CONTACT, geoPoint lat: 50.20923, lon: 15.83277, locations facility: Fakultni Nemocnice Olomouc, status: RECRUITING, city: Olomouc, country: Czechia, contacts name: Karel Krejci, role: CONTACT, geoPoint lat: 49.59552, lon: 17.25175, locations facility: Institut Klinicke a Experimentalni Mediciny, status: RECRUITING, city: Praha, country: Czechia, contacts name: Ondrej Viklicky, role: CONTACT, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Vseobecna Fakultni Nemocnice v Praze, status: RECRUITING, city: Praha, country: Czechia, contacts name: Vladimir Tesar, role: CONTACT, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Hospital Clinic Barcelona, status: RECRUITING, city: Barcelona, state: L'eixample, zip: 08036, country: Spain, contacts name: Marc Xipell Font, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario 12 de Octubre, status: RECRUITING, city: Madrid, state: Usera, zip: 28041, country: Spain, contacts name: Enrique Morales, role: CONTACT, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Hospital Universitario Vall d'Hebron, status: RECRUITING, city: Barcelona, country: Spain, contacts name: Irene Agraz Pamplona, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitario Reina Sofia, status: RECRUITING, city: Córdoba, zip: 14004, country: Spain, contacts name: Cristina Rabasco, role: CONTACT, geoPoint lat: 37.89155, lon: -4.77275, locations facility: Hospital Universitario Virgen de las Nieves, status: RECRUITING, city: Granada, zip: 18014, country: Spain, contacts name: Rafael Jose Esteban de la Rosa, role: CONTACT, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Royal Free London NHS Foundation Trust, status: RECRUITING, city: London, zip: NW3 2QG, country: United Kingdom, contacts name: Daniel Gale, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Great Ormond Street Hospital for Children, status: NOT_YET_RECRUITING, city: London, zip: WC1N 3JH, country: United Kingdom, contacts name: Zainab Arslan, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Royal Manchester Children's Hospital, status: RECRUITING, city: Manchester, zip: M13 9WL, country: United Kingdom, contacts name: Rachel Lennon, role: CONTACT, geoPoint lat: 53.48095, lon: -2.23743, locations facility: Nottingham City Hospital, status: RECRUITING, city: Nottingham, country: United Kingdom, contacts name: Matthew Hall, role: CONTACT, geoPoint lat: 52.9536, lon: -1.15047, hasResults: False