Trial · NCT06274489
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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) |
| Other | Percentage of Patients With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in ECGs from baseline by visit. ECGs should be collected in triplicate, 1 to 3 minutes apart, and read locally |
| Other | Percentage of Patients With Clinically Significant Changes in Physical Examination | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in physical examinations from baseline by visit. Physical examinations will include general appearance, skin, head, ears, eyes, nose, throat, neck, lungs, heart, abdomen, musculoskeletal, extremities, and neurological systems |
| Other | Percentage of Patients With Clinically Significant Changes in Hematology, Serum Chemistry, Urinalysis, and Thyroid Function | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in hematology, serum chemistry, urinalysis, and thyroid function from baseline by visit |
| Other | Percentage of Patients With Clinically Significant Changes in Hearing Audiometric Testing (Bone-conduction) | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in hearing audiometric testing from baseline by visit. Pure tone audiometry (PTA) bone conduction thresholds will be conducted at frequencies 500, 1000, 2000, and 4000 Hz. |
| Other | Percentage of Patients With Clinically Significant Changes in Hearing Audiometric Testing (Air-conduction) | From baseline by visit up to week 28 (study visit 9, Follow-Up) | Clinically significant changes in hearing audiometric testing from baseline by visit. Pure tone audiometry (PTA) air conduction thresholds will be conducted at frequencies 250, 500, 1000, 2000, 4000, and 8000 Hz. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT06274489/registered