Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: Clinical Trial Considerations - Live Stream

A Scientific Workshop Co-Sponsored by the National Kidney Foundation and the US Food and Drug Administration

Thank you for your interest in the Scientific Workshop on Developing Treatments for Early Stages of Common, Chronic Kidney Diseases: Clinical Trial Considerations, co-sponsored by the National Kidney Foundation and the US Food and Drug Administration. The overall goal of the meeting was to obtain input from the wider community of multiple stakeholders regarding whether there is value in treatment and prevention of early common kidney diseases, on the design of such trials including defining the target population and optimal endpoint, as well as the size and nature of the safety database needed to support regulatory approval. The meeting was held on December 14 and 17, 2020. The agenda and recording of the sessions can be viewed below.

MEETING AGENDA

Monday, December 14

(times indicated in EST)
8:00 – 8:10
Welcome
Kerry Willis
8:10 – 8:30
Opening Remarks
Lesley Inker
8:30 – 9:00
Conceptual Framework
Hiddo Lambers Heerspink
9:00 – 9:30
Use of high-risk groups as a target for trials in early CKD
Morgan Grams
9:30 – 10:00
Cost benefit for treating early stage disease
Phil McEwan
10:10 – 10:30
Break
10:30 – 11:15
Regulatory perspective on establishment of drug safety
Aliza Thompson
Hrefna Guðmundsdóttir
11:15 – 11:45
Patient perspective for drugs designed to treat early CKD
Kelli Collins
Patient Panelists

Session 1

Session 2

Thursday, December 17

(times indicated in EST)
2:00 – 2:30
Presentation of breakout groups reports
Lesley Inker and Hiddo Lambers Heerspink
2:30 – 4:00
Summary, synthesis, and discussion