Alport SyndromePhase 1/2NCT06274489
A Study to Evaluate Setanaxib in Patients With Alport Syndrome
A Phase 1/2 study testing Setanaxib in people with Alport Syndrome, run by Calliditas Therapeutics AB at 17 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Alport Syndrome
- What is being tested?
- Setanaxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 27 Nov 2023to 25 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients aged 12 to 50 years inclusive, at the time of informed consent/assent. For sites in the European Union: Male or female patients aged 18 to 50 years, inclusive, at the time of informed consent;
- Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome [ie, COL4A3, COL4A4, or COL4A5]); Patients with a variant of uncertain significance should not be included in the study;
- Note: Genetic test results are to be available prior to initiating other Screening procedures. In cases where genetic testing results are not available but the patient is likely to fulfill the other inclusion and exclusion criteria and has provided consent/assent, a sample for genetic testing should be processed locally and the Screening Period duration can be prolonged with the time it takes to receive the genetic test results. All other Screening assessments must be completed within 4 weeks (± 7 days) prior to randomization.
- Weight ≥40 kg;
- Willing and able to give informed consent (and assent, where applicable), in accordance with local age requirements, and to comply with the requirements of the study;
- Female patients of childbearing potential must use a highly effective method of contraception to prevent pregnancy for ≥4 weeks before randomization and must agree to continue strict contraception (as specified in 5c) up to 90 days after the last dose of investigational medicinal product (IMP);
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- For the purposes of this study, women of childbearing potential (WOCBP) are defined as "fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy";
- Postmenopausal state is defined as no menses for 12 months without an alternative medical cause. In female patients who are not using hormonal contraception or hormonal replacement therapy but with suspected menopause and less than 12 months of amenorrhea, a high follicle-stimulating hormone level in the postmenopausal range will be required at Screening to confirm a postmenopausal state; and
- Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods include the following:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal);
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable);
- Intrauterine device;
- Intrauterine hormone-releasing system;
- Bilateral tubal occlusion;
- Vasectomized partner; and
- Sexual abstinence (refraining from heterosexual intercourse during the entire period of risk associated with the study treatments, ie, up to 90 days after the last dose of IMP). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, symptothermal, or post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
- Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Visit 3 (after randomization and before dosing);
- Male patients with female partners of childbearing potential must be willing to use a condom and require their partner to use a highly effective contraceptive method (as defined in the list in inclusion criterion 5c). Female condom and male condom should not be used together. This requirement begins at the time of informed consent/assent and ends 90 days after receiving the last dose of IMP;
- Male patients must be willing not to donate sperm and female study patients must be willing not to donate eggs from baseline until 90 days after the last dose of IMP;
- Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at Study Visit 1 or 2, calculated at the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula for patients ≥18 years of age and the revised bedside Schwartz formula for patients 12 to 17 years of age;
- Proteinuria (urine protein to creatinine ratio [UPCR] ≥90 mg/mmol [0.8 g/g]) at 2 consecutive measurements (24-hour urine sampling), separated by at least 2 weeks and calculated by the central laboratory;
- Receiving maximum allowed dose or maximum-tolerated daily dose of an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin II type I receptor blocker (ARB) that has been stable for at least 8 weeks prior to consent/assent; and Note: A stable dose is defined as a dose within 25% of the dose at randomization. Note: Patients with proven intolerance to ACEi and ARB are allowed in the study.
- Note: Sodium/glucose co-transporter 2 inhibitors are allowed provided they have been given at the same dose for at least 8 weeks prior to Screening and are given at the same dose during the study.
- Systolic and diastolic blood pressure ≤95th percentile, based on the patient's age and height for patients 12 to 17 years of age or with ≤130 mmHg systolic blood pressure and ≤80 mmHg diastolic blood pressure for patients ≥18 years of age. Note: At least 1 blood pressure measurement during Screening (Study Visit 1 or 2) should be within these limits. Blood pressure will be measured after resting in the supine position for at least 5 minutes and will be measured 3 times with each measurement separated by at least 1 minute (the lowest value will be recorded on the electronic case report form).
Who cannot join
- Has ongoing chronic hemodialysis or peritoneal dialysis;
- Has a history of kidney transplant;
- Has other causes of chronic kidney disease (CKD) (even if not yet on hemodialysis), including but not limited to other heritable disorders leading to CKD, diabetic nephropathy, hypertensive nephropathy, lupus nephritis, and immunoglobulin A nephropathy;
- Has been treated with any investigational agent within 12 weeks of signing informed consent/assent or 5 half-lives of the investigational agent (if known), whichever is longer, or current enrollment in an interventional clinical study;
- Has had prior treatment with setanaxib;
- Has known malignancy that is progressing or requires active treatment, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has undergone potentially curative therapy, or malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of study drug and of low potential risk for recurrence;
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- Positive urine drug screen (if not due to prescription use of a concomitant medication, as confirmed by the Investigator) at Screening. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening Visit 1 may be included in the study. Medicinal cannabis and cannabidiol products are not exclusionary and may be allowed if the prescription and diagnosis are reviewed and approved by the Investigator;
- Has an active HIV infection or acute or chronic hepatitis B or C infection, confirmed at Screening;
- Has had a surgery (eg, gastric bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator);
- Has a positive pregnancy test at Study Visit 2 (Screening) and/or Study Visit 3 (Day 1) (WOCBP only) or is breastfeeding; Note: If a randomized patient has a positive pregnancy test at Study Visit 3 (Day 1), they will be considered a patient withdrawn for non-safety reasons.
- Has evidence of any of the following cardiac conduction abnormalities at Screening or Day 1 (pre-dose): a QTcF interval >450 milliseconds for male patients or >470 milliseconds for female patients, or a PR interval ≥220 milliseconds; Note: Patients with a second or third degree atrioventricular block are to be excluded.
- Has a history of aplastic anemia, or any current marked anemia, defined as hemoglobin <10.0 g/dL;
- Has uncontrolled hypothyroidism. Patients with subclinical hypothyroidism may be included. Subclinical hypothyroidism is defined biochemically as a normal serum free thyroxine (T4) concentration in the presence of an elevated serum thyroid-stimulating hormone (TSH) concentration;
- Has any laboratory abnormality or condition that, in the opinion of the Investigator, could interfere with or compromise a patient's treatment, assessment, or compliance with the Protocol and/or study procedures;
- Has any other condition that, in the opinion of the Investigator, constitutes a risk or contraindication for the participation of the patient in the study, or that could interfere with the study objectives, conduct, or evaluation;
- Uses medications known to be potent cytochrome P450 (CYP) 3A4 inhibitors (itraconazole, lopinavir/itonavir, telaprevir, clarithromycin, ritonavir, ketoconazole, indinavir/ritonavir, conivaptan, and voriconazole), potent CYP3A4 inducers (avasimibe, carbamazepine, enzalutamide, mitotane, nevirapine, phenobarbital, phenytoin, rifabutin, rifampicin, rifapentine, and St John's wort), or potent uridine 5'-diphospho-glucuronosyltransferase 1A9 inhibitors and inducers (mefenamic acid and rifampicin) within 21 days prior to study drug administration;
- Has known psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events (AEs), or compromise the ability of the patient to give written informed consent/assent;
- Has known hypersensitivity or intolerance to setanaxib or to any of its excipients;
- Has a history of chronic liver disease (eg, primary biliary cholangitis, alcoholic liver disease, chronic viral hepatitis including hepatitis B and C, non-alcoholic fatty liver disease, and hemochromatosis);
- Has plasma alanine aminotransferase and/or aspartate aminotransferase >3 x the upper limit of normal (ULN) at Study Visit 1 or 2 (Screening);
- Has total bilirubin >2 x ULN at Study Visit 1 or 2 (Screening); or
- Has international normalized ratio >1.2 at Study Visit 1 or 2 (Screening) (criterion not applicable for patients on anticoagulant therapy).
Trial locations and contacts
17 sites in 5 countries.
17 sites in 5 countries
Spain7 sites
Fundacio Puigvert
Barcelona, 08025
Hospital Clinic Barcelona
Barcelona, 08036
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario 12 de Octubre
Madrid, Usera, 28041
Hospital Fundacion Jimenez Diaz
Madrid, 28040
Czechia4 sites
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Fakultni Nemocnice Olomouc
Olomouc
Institut Klinicke a Experimentalni Mediciny
Prague
Vseobecna Fakultni Nemocnice v Praze
Prague
United Kingdom4 sites
Royal Free London NHS Foundation Trust
London, NW3 2QG
Great Ormond Street Hospital for Children
London, WC1N 3JH
Royal Manchester Children's Hospital
Manchester, M13 9WL
Nottingham City Hospital
Nottingham
About this study
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the NOX1/4 Inhibitor Setanaxib in Patients With Alport Syndrome
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.
- Conditions
- Alport Syndrome
- Being tested
- Setanaxib, Placebo
- Medical subject headings
- Nephritis, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetanaxibDrug
Setanaxib (formerly GKT137831) is a first-in-class inhibitor of the human protein NADPH NOX1/4. It is a low molecular weight organic molecule and a member of the pyrazolopyridine dione chemical class.
PlaceboDrug
Matching film-coated placebo tablets, containing only excipients
| Study group | Role | What they receive |
|---|---|---|
| Setanaxib | Experimental | Patients will receive the following setanaxib doses according to age at the time of consent/assent:
* For patients aged 12 to 17 years 1200 mg/day: 2 tablets in the morning (800 mg) and 1 tablet in the evening (400 mg)
* For patients aged ≥18 years 1600 mg/day: 2 tablets in the morning (800 mg) and 2 tablets in the evening (800 mg) Receives: Drug: Setanaxib |
| Setanaxib placebo | Placebo comparator | Matching placebo will be provided. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Serious Adverse Events (SAEs)
Count and percentage of patients experiencing SAEs
Measured: From informed consent up to 30 days post-final dose, up to 32 weeks
Percentage of Patients With Treatment-emergent Adverse Events of Special Interest (AESIs)
Count and percentage of patients experiencing treatment-emergent AEISIs. CTCAE Grade ≥2 anemia will be considered an AESI. During the course of the study, additional AESIs may be identified by the Sponsor
Measured: From informed consent up to 30 days post-final dose
Secondary outcomes (6)
The Ratio of Urine Protein to Creatinine Ratio (UPCR) Analysed in 24-hour Urine Sample
The ratio of UPCR at 24 weeks compared to baseline
Measured: At baseline and week 24
Percentage of Patients With a 25% Reduction in UPCR Analysed in 24-hour Urine Sample
The proportions of patients achieving a 25% reduction in UPCR at 24 weeks from baseline in the setanaxib group will be compared to placebo group
Measured: At baseline and week 24
The Ratio of Estimated Glomerular Filtration Rate (eGFR) at 24 Weeks Compared to Baseline.
Measured: At baseline and Week 24.
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)
Measured: within 90 minutes prior to dose and 0-, 1-, 2-, 3-, 4- and 6-hours post-dose at week 2; and prior to dose at weeks 12 and 24
Pre-dose and Post-dose Plasma Concentrations of Setanaxib and GKT138184 Measured as the Minimum Plasma Concentration at Steady State (Cmin-ss)
Measured: within 90 minutes prior to dose and 0-, 1-, 2-, 3-, 4- and 6-hours post-dose at week 2; and prior to dose at weeks 12 and 24
Pre-dose and Post-dose Plasma Concentrations of Setanaxib and GKT138184 Measured as the Maximum Plasma Concentration at Steady State (Cmax-ss)
Measured: within 90 minutes prior to dose and 0-, 1-, 2-, 3-, 4- and 6-hours post-dose at week 2; and prior to dose at weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start27 Nov 2023
- Primary completion24 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alport SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calliditas Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274489
- Sponsor's protocol ID
- GSN000500
- Status last verified
- Apr 2026
- First submitted
- 15 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
PubMed 40938675
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the NOX1/4 Inhibitor Setanaxib in Patients With Alport Syndrome
- ClinicalTrials.gov ID
- NCT06274489
- Acronym / sponsor ID
- GSN000500
- Conditions
- Alport Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Calliditas Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Posted 13 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Setanaxib | Experimental | Drug: SetanaxibPatients will receive the following setanaxib doses according to age at the time of consent/assent: * For patients aged 12 to 17 years 1200 mg/day: 2 tablets in the morning (800 mg) and 1 tablet in the evening (400 mg) * For patients aged ≥18 years 1600 mg/day: 2 tablets in the morning (800 mg) and 2 tablets in the evening (800 mg) |
| Setanaxib placebo | Placebo comparator | Drug: PlaceboMatching placebo will be provided. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (24 listed)
- Male or female patients aged 12 to 50 years inclusive, at the time of informed consent/assent. For sites in the European Union: Male or female patients aged 18 to 50 years, inclusive, at the time of informed consent;
- Diagnosis of Alport syndrome by genetic testing (documented mutation in a gene associated with Alport syndrome [ie, COL4A3, COL4A4, or COL4A5]); Patients with a variant of uncertain significance should not be included in the study;
- Note: Genetic test results are to be available prior to initiating other Screening procedures. In cases where genetic testing results are not available but the patient is likely to fulfill the other inclusion and exclusion criteria and has provided consent/assent, a sample for genetic testing should be processed locally and the Screening Period duration can be prolonged with the time it takes to receive the genetic test results. All other Screening assessments must be completed within 4 weeks (± 7 days) prior to randomization.
- Weight ≥40 kg;
- Willing and able to give informed consent (and assent, where applicable), in accordance with local age requirements, and to comply with the requirements of the study;
Key exclusion criteria (22 listed)
- Has ongoing chronic hemodialysis or peritoneal dialysis;
- Has a history of kidney transplant;
- Has other causes of chronic kidney disease (CKD) (even if not yet on hemodialysis), including but not limited to other heritable disorders leading to CKD, diabetic nephropathy, hypertensive nephropathy, lupus nephritis, and immunoglobulin A nephropathy;
- Has been treated with any investigational agent within 12 weeks of signing informed consent/assent or 5 half-lives of the investigational agent (if known), whichever is longer, or current enrollment in an interventional clinical study;
- Has had prior treatment with setanaxib;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SetanaxibSetanaxib (formerly GKT137831) is a first-in-class inhibitor of the human protein NADPH NOX1/4. It is a low molecular weight organic molecule and a member of the pyrazolopyridine dione chemical class. | Drug | Setanaxib |
| PlaceboMatching film-coated placebo tablets, containing only excipients | Drug | Setanaxib placebo |
Primary outcome
Percentage of Patients With Serious Adverse Events (SAEs)
Time frame: From informed consent up to 30 days post-final dose, up to 32 weeks
Count and percentage of patients experiencing SAEs
Percentage of Patients With Treatment-emergent Adverse Events of Special Interest (AESIs)
Time frame: From informed consent up to 30 days post-final dose
Count and percentage of patients experiencing treatment-emergent AEISIs. CTCAE Grade ≥2 anemia will be considered an AESI. During the course of the study, additional AESIs may be identified by the Sponsor
6 secondary outcomes
The Ratio of Urine Protein to Creatinine Ratio (UPCR) Analysed in 24-hour Urine Sample
Time frame: At baseline and week 24
Percentage of Patients With a 25% Reduction in UPCR Analysed in 24-hour Urine Sample
Time frame: At baseline and week 24
The Ratio of Estimated Glomerular Filtration Rate (eGFR) at 24 Weeks Compared to Baseline.
Time frame: At baseline and Week 24.
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)
Time frame: within 90 minutes prior to dose and 0-, 1-, 2-, 3-, 4- and 6-hours post-dose at week 2; and prior to dose at weeks 12 and 24
Pre-dose and Post-dose Plasma Concentrations of Setanaxib and GKT138184 Measured as the Minimum Plasma Concentration at Steady State (Cmin-ss)
Time frame: within 90 minutes prior to dose and 0-, 1-, 2-, 3-, 4- and 6-hours post-dose at week 2; and prior to dose at weeks 12 and 24
Pre-dose and Post-dose Plasma Concentrations of Setanaxib and GKT138184 Measured as the Maximum Plasma Concentration at Steady State (Cmax-ss)
Time frame: within 90 minutes prior to dose and 0-, 1-, 2-, 3-, 4- and 6-hours post-dose at week 2; and prior to dose at weeks 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40938675Rheault MN. Treatment Approaches for Alport Syndrome. J Am Soc Nephrol. 2026 Jan 1;37(1):172-179. doi: 10.1681/ASN.0000000897. Epub 2025 Sep 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Setanaxib in people with Alport Syndrome, run by Calliditas Therapeutics AB at 17 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, Czechia, United Kingdom, Austria, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Serious Adverse Events (SAEs) (time frame: From informed consent up to 30 days post-final dose, up to 32 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06274489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.