In the face of challenges both predictable and unforeseen, Worldwide Clinical Trials brought our sponsor’s first FDA-approved oral therapy for lupus nephritis (LN) across the finish line on time.
Recruitment: Experienced Sites with Inexperienced Patients
Patients at sites with significant experience with LN trials are typically already participating in a study. This study required sites familiar with LN clinical trials with clinically qualifying patients not already participating in LN studies.
Clinical: Unpredictable Medical Events
Within this study, strict protocol adherence would be a challenge. The investigational product was to be administered at the start of a proteinuria flare, so patients needed to recognize symptoms indicating when to visit the site.
Find out more in the available case study.