Pilot Clinical Trials in Pediatric Chronic Kidney Disease

Event Details

Background

Much has been learned about the natural history of Chronic Kidney Disease (CKD) in children, but few therapies have been tested in a robust way. There is a need to assess potential novel treatments through pilot studies to determine the optimal design for a definitive, full-scale trial. The need includes therapies to slow or reverse disease progression, as well as therapies to ameliorate the many comorbidities associated with pediatric CKD. While FDA allows some extrapolation of data from adult studies for drug labeling, the differences in both disease etiology and age-specific comorbidities require appropriate studies in the appropriate population. This workshop will explore some potential therapeutic target areas for children with CKD.

Planning Committee

Dr. Marva Moxey-Mims
Dr. Susan Furth
Dr. Tammy Brady
Dr. Melissa Cadnapaphornchai
Dr. Frederick Kaskel
Dr. Keisha Gibson
Dr. Joshua Zaritsky
Dr. Bradley Warady

Registration Deadline

July 14, 2016

Agenda

July 22, 2016

7:30 a.m. – 8:00 a.m.

Registration

8:00 a.m. – 8:15 a.m.

Opening Remarks
Robert Star and Marva Moxey-Mims

8:15 a.m. – 8:45 a.m.

Defining Risk Factors for CKD Progression
Sue Furth

8:45 a.m. – 9:15 a.m.

Statistical “Pitfalls”
Tom Greene

9:15 a.m. – 9:45 a.m.

Regulatory Issues
Lynne Yao

9:45 a.m. – 10:00 a.m.

Break

10:00 a.m. – 10:20 a.m.

Blood Pressure Control
Franz Schaefer

10:20 a.m. – 10:40 a.m.

Lipids
Jeff Saland

10:40 a.m. – 11:00 a.m.

Uric Acid
Dan Feig

11:00 a.m. – 11:40 a.m.

Anemia/Iron/ESAs
Meredith Atkinson and Michelle Rheault

11:40 a.m. – 12:20 p.m.

PTH – Bone/CVD
Michelle Denburg and Rukshana Shroff

12:20 p.m. – 1:30 p.m.

Lunch

1:30 p.m. – 4:00 p.m.

Breakout Groups

4:00 p.m. – 5:00 p.m.

Reports from Breakout Groups

5:00 p.m.

Closing Remarks and Adjournment