Following decades of no approved therapies for
various forms of Nephrotic Syndrome, potentially paradigm-changing
therapies are now on the horizon. Increased understanding in
disease pathophysiology, regulatory approval evolutions, and
breakthroughs within drug development have led to a recent surge in the
number of NS clinical trials. The continued success of these potential
future therapies now requires unprecedented collaborations of
collective stakeholders and champions in this community.
This will be an action-oriented
meeting bringing together various senior level stakeholders from
government, clinical practice, professional societies, industry, and
patients to enhance clinical trial participation.
Focusing on five key drivers of Nephrotic
Syndrome trial recruitment:
• Pediatric Inclusion– methods to increase pediatric
inclusion in various studies •
Study Overlap – accommodating numerous studies and
patient segmentation techniques
• Patients – registries, US and ex-US inclusion,
various patient recruitment initiatives •
Pathology – reporting practices and patient
candidate identification •
Clinicians – securing support of nephrology at large
Key attendees, Drs. Norm Stockbridge and Aliza Thompson of the FDA's Center for Drug Evaluation and Research, will be joined by other leaders in the field and NephCure to launch this meeting and further the work generated from it.
Please respond by September 17 to ensure your participation. There is no cost to attend this meeting.
For questions, please contact Chelsey Fix: CFix@NephCure.org
NephCure Kidney International
Kidney Health Initiative (of The ASN)
Members of the renal pathology community
and representatives from the Division of Cardiovascular and Renal Products of FDA
November 15, 2018
Time 8:00 AM Wardman Park Marriott, Washington, DC 20008
Meeting time: 8 AM - 4 PM EST. For more information, please contact Chelsey Fix: CFix@NephCure.org