Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy
Phase 2
Completed
NCT05834738
| Condition | IgA Nephropathy, Immunoglobulin A Nephropathy |
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| Phase | Phase 2 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Completed |
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| Enrollment | 54 participants |
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| Interventions | Atrasentan, Atrasentan |
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| Start date | Jul 20, 2023 |
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| Completion date | Jun 30, 2025 |
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| Results posted | Jul 20, 2026 |
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Summary
The ASSIST study was a phase 2, double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy (IgAN) while on background standard of care therapy and an SGLT2 inhibitor (SGLT2i).
Percentage Change in Proteinuria (UPCR From a 24-Hour Urine Collection) From Baseline to Week 12
From Baseline to Week 12 · percentage change in UPCR
| Atrasentan | -30.7 percentage change in UPCR |
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| Placebo | -7.2 percentage change in UPCR |
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| p-value | 0.0006 |
| % Mean treatment difference | -25.3 (95% CI -36.8–-11.7) |
Open in BENITIONS
View on ClinicalTrials.gov
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