The Importance of Patient Participation in C3G Clinical Trials

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Clinical Trials in C3G with FDA-Approved Medications: Summary for Physicians

This summary addresses key points from a professional discussion between Andrew S. Bomback, MD, MPH; and Sayna Norouzi, MD, regarding the challenges of conducting clinical trials for C3G following FDA approval of treatments.

Key Points:

• Changing Trial Landscape: With FDA-approved medications for C3G now available, the traditional clinical trial paradigm faces challenges, as clinicians appropriately prefer to try approved treatments before enrolling patients in trials.
• Patient Participation Impact: Patients with C3G have been instrumental in advancing research by participating in clinical trials at unexpectedly high rates, consenting to repeat biopsies, and remaining in extension studies to provide long-term glomerular filtration rate data.
• Diminishing Enrollment: Similar to patterns observed in lupus nephritis and membranous nephropathy after effective treatments became standard of care, C3G trial enrollment is likely to decrease as approved therapies become available.
• Trial Design Challenges: Future trial designs may need modification to remain ethically sound and attractive to patients who now have treatment alternatives.

Access Considerations: As Brendon Neuen, MD,noted, regulatory approval does not guarantee access, particularly globally. Many patients worldwide will still struggle to access new therapies, potentially preserving a role for clinical trials even with approved medications available.

• Current Trial Status: Andrew S. Bomback, MD, MPH, mentioned he currently has no active trials specifically for C3G at his center, noting one company canceled their program for a drug with a potentially different mechanism of action.

This evolving landscape suggests the need for thoughtful consideration of trial design, patient populations, and global access factors when planning future C3G research.