BENITIONSClinical Trial Intelligence

Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects With IgA Nephropathy

Phase 2 Completed NCT05834738

ConditionIgA Nephropathy, Immunoglobulin A Nephropathy
PhasePhase 2
SponsorNovartis Pharmaceuticals
StatusCompleted
Enrollment54 participants
InterventionsAtrasentan, Atrasentan
Start dateJul 20, 2023
Completion dateJun 30, 2025
Results postedJul 20, 2026

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
Placebo-7.2 percentage change in UPCR
p-value0.0006
% Mean treatment difference-25.3 (95% CI -36.8–-11.7)

Open in BENITIONS View on ClinicalTrials.gov

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