AKI Clinical Trial Design Workshop - December 2–3, 2010, Natcher Conference Center, National Institute of Health, Building 45, Bethesda, MD 20892
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Draft Agenda

DAY 1:  Thursday December 2, 2010 
   
7:00 – 8:00 a.m. Registration
   
8:00 – 8:15 a.m.

Opening Remarks and Objectives
Drs. Robert Star, Paul Kimmel and Bruce Molitoris
   
8:15 – 10:00 a.m.

Lessons Learned From AKI Meetings/Trials
Moderator:  Dr. John Stokes

  • State of the Art Lecture:  Challenges and Successes in AKI trials – Past Trials and AKIN Viewpoints  –Dr. Paul Palevsky (30 minutes, followed by 15 minutes of discussion)
  • Risk Assessment Analysis and Study Populations  – Dr. Adeera Levin (20 minutes, followed by 10 minutes of discussion)
  • Resources for AKI studies – Experience From an O’Brien Center  – Dr. Ravindra Mehta (20 minutes, followed by 10 minutes of discussion)
   
10:00 – 10:20 a.m.   BREAK
   
10:20 – 12:30 p.m. Challenges in Clinical Trial Design (I) – Planning Studies for AKI (15 minutes, followed by 10 minutes of discussion)
Moderator:  Dr. Glenn Chertow
  • Lessons for Nephrologists From Opthalmology – Choosing Endpoints That Work and Are Accepted  – Dr. Frederick Ferris
  • Lessons for Nephrologists From Rheumatology – Initiating Anti-Cytokine Therapies – Dr. Zeb Horowitz
  • Challenges and Successes in the ICU – Choosing Interventions and Endpoints – Dr. Taylor Thompson
  • Challenges and Successes in Sepsis – Dr. William Macias
  • Why Good Trials Go Bad  –  Dr. John Lachin
   
12:30 – 2:00 p.m. Challenges in Clinical Trial Design (II) – Planning Studies for AKI (20 minutes, followed by 10 minutes of discussion) (Working Lunch)
Moderator:  Dr. David Warnock
  • Lessons for Nephrologists – AKI Clinical Trials – An FDA Viewpoint – Dr. Aliza Thompson
  • Lessons for Nephrologists – Primary Prevention Studies – A Design Viewpoint  – Dr. Glenn Chertow
  • Lessons for Nephrologists – Secondary Prevention Studies – A Design Viewpoint – Dr. James Tumlin
   
2:00 – 3:30 p.m. Breakout Sessions – Dr. Paul Kimmel
Group Discussion:
  1. Adverse Events/Pilot and Feasibility Issues
    Moderators:  Drs. Sarah Faubel and John Kellum
  2. Tenable End-points for AKI Trials
    Moderators:  Drs. Glenn Chertow and Ron Wald
  3. Patient Selection—Inclusion/Exclusion Criteria
    Moderators:  Drs. Adeera Levin and Sushrut Waikar
  4. Biomarkers/Surrogate Markers
    Moderators:  Drs. Patrick Murray and Chirag Parikh
  5. Power and Sample Size Issues
    Moderators:      Drs. Alan Go and Andrew Shaw
   
3:30 – 3:45 p.m. BREAK
   
3:45 – 6:00 p.m. Breakout Sessions – Reports and Group Discussion 
   
6:00 –7:00 p.m. Possible Poster Session
   
7:00 p.m. ADJOURN
   
DAY 2:  Friday December 3, 2010
   
7:00 – 7:30 a.m. Registration
   
7:30 – 9:00 a.m. Drug Targets (20 minutes, followed by 10 minutes of discussion)
Moderator:  Dr. Sudhir Shah
  • Drugs Targeting Endothelial and Epithelial Cells – Dr. Bruce Molitoris
  • Drugs Targeting Inflammatory Cells – Dr. Mark Okusa
  • Stem Cells and Targeting Drugs – Dr. Christof Westenfelder
   
9:00 – 10:00 a.m.

NIH Partnership Guideposts (20 minutes, followed by 10 minutes of discussion)
Moderator:  Dr. Paul Kimmel

  • Public – Private Partnerships/Collaborative Opportunities/An NIH View  – Dr. Shawnmarie Mayrand-Chung
  • Intellectual Property – An NIDDK View  –  Ms. Anna Amar
   
10:00 – 10:30 a.m. BREAK
   
10:30 – 12:30 p.m. Drugs for Clinical Trials in AKI – Industry Round Table (10 minutes followed by 5 minutes of discussion)
Moderator:  Dr. Paul Kimmel

  • Industry 1 – TBD
  • Industry 2 – TBD
  • Industry 3 – TBD
  • Industry 4 – TBD
  • Industry 5 – TBD
  • Industry 6 – TBD
  • Industry 7 – TBD
  • Industry 8 – TBD
   
12:30 – 2:30 p.m. Designing a Clinical Trial Using Novel Drugs (Working Lunch)

Breakout Sessions:
Group Discussion:

  • Primary Prevention Trial #1:  Postelective Surgery (Cardiopulmonary Bypass, Abdominal Surgery)
    Moderators:  Drs. Tom Greene and Kathleen Liu

  • Primary Prevention Trial #2:  Radiocontrast
    Moderators:  Drs. Alfred Cheung     and Steven Weisbord

  • Secondary Prevention Trial #1:  Sepsis
    Moderators:  Drs. Lakhmir Chawla     and James Kaufman

  • Secondary Prevention Trial #2:  Trauma/Surgery/ICU
    Moderators:  Drs. Robert Toto and Chi-yuan Hsu
   
2:30 – 2:45 p.m. BREAK
   
2:45 – 4:15 p.m. Reports From the Breakout Sessions
   
4:15 – 5:15 p.m. Discussion/Next Steps
   
5:15 – 5:30 p.m. Summary – Drs. Robert Star and Paul Kimmel
   
5:30 p.m. ADJOURN
   
 
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