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NCT04573478 (atrasentan in IgA Nephropathy): BVCT ex-ante prediction vs. reported outcome

On 6 Jun 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 13 Feb 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04573478
Acronym
ALIGN
Drug Name
atrasentan
Drug MoA
endothelin A receptor antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Immune System Diseases
Indication
IgA Nephropathy
Human Patients
404
Sponsor
Novartis / Chinook Therapeutics
Phase
Phase 3

Prediction of , index 1097

Prospective Prediction
Prediction Index
1097
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
partial SUCCESS (statistically significant clinical benefit for proteinuria yet statistically insignificant clinical benefit for eGFR)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
983 days in advance
Readout Data Interpretation
atrasentan failed to achieve statistically significant improvement in eGFR compared with placebo at week 136 (p=0.057)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function
Phase
Phase 3
Status
Active not recruiting
Enrollment
404
Lead sponsor
Novartis Pharmaceuticals
Conditions
IgA Nephropathy; Immunoglobulin A Nephropathy
Interventions
DRUG: Atrasentan; DRUG: Placebo; DRUG: Zigakibart
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-12-11
Primary completion
2028-04-14
Completion
2028-04-14
Primary outcomes
  • Double-blind period: Change in proteinuria (Up to Week 36 or approximately 9 months)
  • 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)
  • 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)
  • Substudy period: Number of subjects with TEAEs (From substudy baseline to end of treatment, up to 48 weeks)
  • Substudy period: Number of subjects with AESI (From substudy baseline to end of treatment, up to 48 weeks)

NCT04573478 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials