Trial · NCT07498335
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
NCT07498335, Phase 3, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN. Trials, record NCT07498335. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07498335
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
- NCT number
- NCT07498335
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Berger Disease, Bergers Disease, IgA Nephropathy, Immunoglobulin A Nephropathy, Primary IgAN, Nephritis IgA Type, Nephropathy IgA Type
- Interventions
- Drug: Atrasentan
- First posted
- 2026-03-27
- Last updated
- 2026-11-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Proteinuria at Week 36 | Baseline and 36 weeks | The change in urine protein: creatinine ratio (UPCR) from baseline to Week 36 |
| Secondary | Change from Baseline in Proteinuria at Week 36 in participants who experienced ≤ 30% decrease in proteinuria during the 60-day period prior to atrasentan initiation | Baseline and 36 weeks | All cohorts combined |
| Secondary | PK parameters: Cmaxss | Baseline and week 104 | Cmaxss: The maximum (peak) observed plasma concentration (mass x volume-1) |
| Secondary | PK parameters: AUCss | Baseline and week 104 | AUCss: The AUC calculated during a dosing interval at steady state (amount x time x volume-1) |
| Secondary | PK parameters: CLss/F | Baseline and week 104 | CLss/F: Apparent total plasma clearance of after extravascular administration at steady state. (volume x time-1) |
| Secondary | PK parameters: Ctrough | Baseline and week 104 | Ctrough: The pre-dose plasma concentration observed during a dosing interval (mass x volume-1) |
| Secondary | Number of participants with AEs | Baseline and week 104 | Number of participants with AEs and SAEs including abnormal laboratory parameters, and vital signs |
Source ClinicalTrials.gov
Outcomes0
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 |
|---|---|
| 39460694 | BACKGROUND |
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/NCT07498335
GET https://conductscience.org/api/trials/v1/NCT07498335/registered