Trial · NCT04573478
Atrasentan in Patients With IgA Nephropathy
NCT04573478, Phase 3, Active not recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Atrasentan in Patients With IgA Nephropathy. Trials, record NCT04573478. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04573478
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atrasentan in Patients With IgA Nephropathy
- NCT number
- NCT04573478
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 404 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- IgA Nephropathy, Immunoglobulin A Nephropathy
- Interventions
- Atrasentan, Placebo, Zigakibart
- First posted
- 2020-10-05
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 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.
Papers5
The papers the trial lists on ClinicalTrials.gov.
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.
Data dates
The day each source was copied for this release.
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 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/NCT04573478
GET https://conductscience.org/api/trials/v1/NCT04573478/registered