Trial · NCT04573478
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double-blind period: Change in proteinuria | Up to Week 36 or approximately 9 months | The change in urine protein:creatinine ratio (UPCR) from baseline to Week 36. (non-SGLT2i stratum) |
| Primary | Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) | From open-label baseline up to end of treatment visit, up to 48 weeks | Type, incidence, severity, seriousness, and relatedness of TEAEs. |
| Primary | Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload | From open-label baseline up to end of treatment visit, up to 48 weeks | Incidence, severity, seriousness, and relatedness AESIs. |
| Primary | Substudy period: Number of subjects with TEAEs | From substudy baseline to end of treatment, up to 48 weeks | Type, incidence, severity, seriousness, and relatedness of TEAEs |
| Primary | Substudy period: Number of subjects with AESI | From substudy baseline to end of treatment, up to 48 weeks | Incidence, severity, seriousness, and relatedness AESIs. |
| Secondary | Double-blind period: Change in eGFR | Up to Week 136, 4 weeks post end of treatment | Change from Baseline to final study visit (Week 136, 4 weeks post end of treatment) using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation (non-SGLT2i stratum) |
| Secondary | Double-blind period: Percent of subjects meeting the first composite endpoint | Up to approximately 2.6 years | Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study: * At least a 30% reduction in eGFR sustained for at least 30 days * eGFR \<15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis ≥30 days * Kidney transplantation * All-cause mortality |
| Secondary | Double-blind period: Percent of subjects meeting the second composite endpoint | Up to approximately 2.6 years | Percent of subjects in the non-SGLT2i stratum meeting the composite endpoint of experiencing at least one of the following during the study: * At least a 40% reduction in eGFR sustained for at least 30 days * eGFR \<15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis ≥30 days * Kidney transplantation * All-cause mortality |
| Secondary | Double-blind period: Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36 | Baseline to Week 36 | Percentage of subjects with reduction of proteinuria to \< 1 g/day and a 25% decrease in total urine protein from Baseline (non-SGLT2i stratum). |
| Secondary | Double-blind period: Number of Subjects With TEAEs | From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks | Type, incidence, severity, seriousness, and relatedness of TEAEs. |
| Secondary | Double-blind period: Number of Subjects With AESI Including Events of Fluid Overload | From first dose of study drug up to 4 weeks post end of treatment in double-blind period, 136 weeks | Incidence, severity, seriousness, and relatedness AESIs. |
| Secondary | Open-label period: Change in proteinuria | Open-label Baseline to open-label Week 36 | Change in UPCR based on 24-hour urine collection. |
| Secondary | Open-label period: Change in eGFR | Open-label Baseline to open-label Week 52 | Change from open-label Baseline to open-label Week 52 using the CKD-EPI creatinine equation. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT04573478/registered