Trial · NCT06274489
A Study to Evaluate Setanaxib in Patients With Alport Syndrome
NCT06274489, Phase 1, Phase 2, Completed, Asahi Kasei Therapeutics, AB
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate Setanaxib in Patients With Alport Syndrome. Trials, record NCT06274489. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06274489
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Setanaxib in Patients With Alport Syndrome
- NCT number
- NCT06274489
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Asahi Kasei Therapeutics, AB
- Conditions
- Alport Syndrome
- Interventions
- Setanaxib, Placebo
- First posted
- 2024-02-23
- Last updated
- 2026-04-13
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Serious Adverse Events (SAEs) | From informed consent up to 30 days post-final dose, up to 32 weeks | Count and percentage of patients experiencing SAEs |
| Primary | Percentage of Patients With Treatment-emergent Adverse Events of Special Interest (AESIs) | 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 |
| Secondary | The Ratio of Urine Protein to Creatinine Ratio (UPCR) Analysed in 24-hour Urine Sample | At baseline and week 24 | The ratio of UPCR at 24 weeks compared to baseline |
| Secondary | Percentage of Patients With a 25% Reduction in UPCR Analysed in 24-hour Urine Sample | At baseline and week 24 | 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 |
| Secondary | The Ratio of Estimated Glomerular Filtration Rate (eGFR) at 24 Weeks Compared to Baseline. | At baseline and Week 24. | |
| Secondary | 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) | 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 | |
| Secondary | Pre-dose and Post-dose Plasma Concentrations of Setanaxib and GKT138184 Measured as the Minimum Plasma Concentration at Steady State (Cmin-ss) | 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 | |
| Secondary | Pre-dose and Post-dose Plasma Concentrations of Setanaxib and GKT138184 Measured as the Maximum Plasma Concentration at Steady State (Cmax-ss) | 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 | |
| Other | Percentage of Patients With Clinically Significant Changes in Heart Rate | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in heart rate from baseline by visit. Heart rate 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) |
| Other | Percentage of Patients With Clinically Significant Changes Blood Pressure | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in blood pressure from baseline by visit. Systolic and diastolic 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) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40938675 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06274489
GET https://conductscience.org/api/trials/v1/NCT06274489/registered