drugset / Trial / NCT04053764

Study Exploring the Effect of Crizanlizumab on Kidney Function in Patients With Chronic Kidney Disease Caused by Sickle Cell Disease

NCT04053764 ↗

Phase 2 Completed 58 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of the study was to evaluate descriptively the effect of crizanlizumab + standard of care and standard of care alone on renal function in sickle cell disease patients ≥ 16 years with chronic kidney disease due to sickle cell nephropathy.

Timeline

Start
2019-12-10
Primary completion
2023-03-20
Completion
2023-03-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Crizanlizumab + Standard of Care vs Standard of Care (SOC); Odds Ratio (OR) 1.94 (95% CI 0.53 to 7.14) NCT04053764 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Crizanlizumab Monoclonal antibody 5 mg/kg Intravenous

Indications