U.S. Department of Health and Human Services

Reducing the Impact of Chronic Kidney Disease (CKD): Opportunities for Randomized Clinical Trials

7/19/2011 7:00 AM
7/20/2011 7:00 AM
 
No
For questions concerning program content, contact:
Dr. Michael Flessner, NIDDK, NIH
flessnermf@niddk.nih.gov

Dr. Yining Xie, NIDDK, NIH
xieyi@niddk.nih.gov
 
For registration information, contact:
Mary Compton
Conference Planner
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD 20878-1409
Tel:  (301) 670-4990 x249
Fax:  (301) 670-3815
Bethesda
 

Event Details

Meeting Goals:

  1. Discuss critical elements of the study design to optimize the conduct and impact of Phase III clinical trials in CKD.
  2. Identify interventions and therapies for CKD that are currently in clinical trials or are ready to be evaluated in clinical trials.
  3. Discuss mechanisms for pathways of cooperation among industry, academia, government, and patient advocacy groups for CKD trials.

Agenda

DAY 1:  Tuesday, July 19, 2011 

   
7:00 - 8:00 a.m. Registration
   
8:00 - 8:15 a.m. Opening Remarks and Objectives
Dr. Robert Star and Dr. Michael Flessner
   
8:15 - 9:45 a.m. State-of-the-Art Lectures
Moderator:  Dr. Glenn Chertow
  • Lessons from CRIC and CKid:  Defining Risk Factors Relevant to CKD Trials
    Dr. Harold Feldman and Dr. Susan Furth
  • Lessons from CKD Trials (TREAT, AASK, RENALL)
    Dr. Robert Toto
  • Why Good Trials Go Bad
    Dr. Tom Greene
   
9:45 - 10:00 a.m. BREAK
 
10:00 - 12:30 p.m.   Challenges in Clinical Trial Design (I) � Planning Studies for CKD 
Moderator:  Dr. Laura Dember
  • Selection of Study Populations:  Prevention or Interventions to Slow Progression?
    Dr. Julie Lewis
  • Renal Outcomes for Phase III Trials
    Dr. Lawrence Appel
  • Biomarkers for CKD Progression or Risk of Progression
    Dr. Patrick Murray
  • Effect Size and Sample Size Calculations
    Dr. Glenn Chertow
  • Adaptive Designs to Increase Efficiency for Phase II/III Trials
    Dr. Michael Rosenblum
  • SPRINT:  High Risk CKD Subgroup Within a Larger Clinical Trial
    Dr. Alfred Cheung and Dr. David Reboussin
   
12:30 - 1:15 p.m. Lunch (Pre-Purchased Box Lunches in Breakout Rooms)
   
1:15 - 3:40 p.m. Therapies in Phase II/Pilot Studies 
Moderator:  Dr. Flessner
  • Allopurinol
    Dr. Allesandro Doria
  • Antioxidants
    Dr. Jonathan Himmelfarb
  • Bicarbonate
    Dr.  Michal Melamed
  • Mineralocorticoid Receptor Blockers 
    Dr. Robert Toto
  • Non-Pharmacologic Therapies:  Glucose Control, Weight Loss, and Sodium Restriction
    Dr. William Mitch
  • Pentoxifylline
    Dr. Robert Perkins
  • Pirfenidone
    Dr. Kumar Sharma
  • Vitamin D/Phosphate Binding/Dietary Intervention
    Dr. Geoff Block
   
3:45 - 5:15 p.m.
Breakout Sessions
Purpose:  To discuss the critical design elements that are required to bring a medication or maneuver to a Phase III trial. 
Topics for Individual Breakout Sessions:
Group 1
Trial in Children:  Agent To Prevent Progression
Moderators:  Dr. Susan Furth, Dr. Russell Chesney, Dr. James Chan, Dr. Frederick Kaskel, Dr. Lynne Yao, and Dr. David Reboussin
Group 2
Trial in Adults with Bicarbonate  
Moderators:  Dr. Michal Melamed, Dr. Donald Wesson, and Dr. Tom Greene
Group 3 
Trial in Adults with Pentoxifylline
Moderators:  Dr. Robert Perkins and Dr. Linda Fried, NIH Biostatistician
Group 4 
Trial in Adults with Mineralocorticoid Receptor Blocker
Moderators:  Dr. Robert Toto, Dr. Tom Hostetter, and Dr. Michael Rosenblum
Group 5 
Trial in Adults with Phosphate Control/Vitamin D:  
Moderators:  Dr.  Myles Wolf, Dr. Rajnish Mehrota, Dr. Ravi Thadani, and Dr. Glenn Chertow, NIH Biostatistician
Each Group Will Consider the Following Issues:
  1. Define Trial Question:  Preliminary Data?

  2. Renal Endpoints for Phase III CKD Trial  
    1. Proteinuria as an endpoint? Are there other surrogate endpoints?
    2. Creatinine (or cystatin C)-based endpoints:  Doubling? Slope?
    3. Are CKD staging tools feasible endpoints?
    4. What are the obstacles that have prevented the design and execution of outcome studies for renal-specific endpoints?

  3. Non-Renal Endpoints for Phase III CKD Trials
    1. Non-renal endpoints (CVD, mortality, hospitalization)
    2. Which should be used in either Phase II or Phase III studies?
    3. Should these be primary or secondary endpoints in Phase III studies?

  4. Patient Selection and Recruitment
    1. Inclusion/exclusion criteria  (Early disease vs. late disease)
    2. Impact of patient selection on design of study
    3. Should a trial be restricted to proteinuric disease or have a stratum with a target proportion with proteinuria? If yes, how would proteinuria be defined?
    4. Is the recruitment strategy feasible?
    5. Biomarkers for risk stratification
    6. Incorporation of Protocolized Adjunctive Care (Will this agent be added to ACEI or ARB or be substituted for the current standard of care?)

  5. Adverse Events/Pilot and Feasibility Issues:  Dose Selection

  6. Sample Size and Power
   
5:15 - 6:00 p.m. Preliminary Reports From the Breakout Sessions and General Discussion 
   
6:00 p.m. Adjournment
   

DAY 2:  Wednesday, July 20,  2011

   
7:00 - 8:00 a.m. Registration
   
8:00 - 9:00 a.m. Government-Academic-Industry Partnerships
Moderator:  Dr.  Michael Flessner
  • Regulatory Issues:  FDA Viewpoint
    Dr. Aliza Thompson
  • Public Private Partnerships/Collaborative Opportunities/An NIH View
    Dr. Barbara Mittleman
  • Intellectual Property - An NIDDK View
    Ms. Anna Amar
   
9:00 - 9:30 a.m. Break
   
9:30 - 12:00 p.m. Ongoing Industry Trials/Research and Development
Moderator:  Dr. David Warnock 
  • Bardoxolone:  BEACON Trial:
    Dr. Paul Audhya and Dr. Colin Meyer, Reatta Pharmaceuticals
  • CTP-499, a First-in-Class Clinical Development Candidate for Diabetic Nephropathy
    Dr. James Shipley, CoNCERT Pharmaceuticals
  • TBD
    Dr. Thomas Daniel, Celgene Corporation
  • Atrasentan
    Dr. Dennis Andress, Abbott
  • AST-120/EPPIC Program
    Dr. Alan Glicklich, Mitsubishi Tanabe Pharma America
  • ALTITUDE Trial
    Dr. Marc Pfeffer
  • Development of Acthar for Treatment of Diabetic Nephropathy
    Dr. David Young, Questcor Pharmaceuticals
Industry Panel Discussion:  Speaker Panel and Moderator
   
Noon - 3:00 p.m.
Breakout Sessions (Working Lunch) Continued from Day One
Topics for Individual Breakout Sessions:
Group 1
Trial in Children:  Agent To Prevent Progression
Moderators:  Dr. Susan Furth, Dr. Russell Chesney, Dr. James Chan, Dr. Frederick Kaskel, Dr. Lynne Yao, and Dr. David Reboussin
Group 2
Trial in Adults with Bicarbonate  
Moderators:  Dr. Michal Melamed, Dr. Donald Wesson, and Dr.  Tom Greene
Group 3 
Trial in Adults with Pentoxifylline
Moderators:  Dr.  Robert Perkins and Dr. Linda Fried, NIH Biostatistician
Group 4 
Trial in Adults with Mineralocorticoid Receptor Blocker
Moderators:  Dr. Robert Toto, Dr. Tom Hostetter, and Dr. Michael Rosenblum
Group 5 
Trial in Adults with Phosphate Control/Vitamin D  
Moderators:  Dr. Myles Wolf, Dr. Rajnish Mehrota, Dr. Ravi Thadani, and Dr. Glenn Chertow, NIH Biostatistician
   
3:00 - 5:00 p.m. Reports From the Breakout Sessions:  Discussion and Next Steps
   
5:00 - 5:15 p.m.
Summary
Dr. Robert Star and Dr. Michael Flessner
   
5:15 p.m. Adjournment

Directions/Travel

National Institutes of Health (NIH) Visitor Information

The Natcher Auditorium is located on the NIH Campus in Building 45.  For a map, general information, and directions to and around the NIH Campus, visit http://parking.nih.gov/visitor_access_map.htm.   

NIH Security

The NIH, like all federal government facilities, has instituted security measures to ensure the safety of NIH employees, patients, and visitors.  The national threat advisory level is determined by the Department of Homeland Security (http://www.whitehouse.gov/homeland/).   

Perimeter Security

All visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks, and vans will be inspected before being allowed on campus.  Visitors will be asked to show one (1) form of identification (a government-issued photo ID:  driver�s license, passport, green card, etc.) and to state the purpose of their visit.   Be sure to allow at least 15-20 minutes for this vehicle inspection procedure.

Building Security

Due to the checking of IDs at the perimeter, employees and visitors will not be required to show their ID again to gain access to the majority of buildings on the NIH Campus during the normal business day.
 
Employees and visitors should continue to wear their identification prominently at all times while on campus.

Weekday Campus Access

Visitors, including meeting attendees, patients, contractors, vendors, and delivery persons:  All visitors must use the following entrances (see the Visitor Map at http://parking.nih.gov/visitor_access_map.htm): 
  • Rockville Pike at South Drive (Metro):    Regular weekday schedule:  Open 24 hours for inbound and outbound traffic.
  • Old Georgetown Road at Center Drive:    This entrance is primarily for commercial vehicles and visitors.

Regular weekday schedule:

5:00 a.m. to 2:00 p.m. - Inbound traffic only
2:00 p.m. to 7:00 p.m. - Inbound and outbound traffic
7:00 p.m. to 5:00 a.m. - Closed to all traffic 

DRIVING DIRECTIONS TO NIH

From Points North and East:
Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring.  Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue).  Follow signs for Route 355 South and stay in the right lane.  Travel approximately 1 mile and turn right at the light onto South Drive.  Pass through NIH security and follow the signs to Building 45.
 
From Points North and West:  
Take I-270 South to I-495 East (Capital Beltway) toward Washington, DC.  Stay in one of the three left lanes.  Follow signs for Route 355 South, a left-lane exit, onto Wisconsin Avenue.  Travel approximately 1 mile and turn right at the light onto South Drive.  Pass through NIH security and follow the signs to Building 45.
 
From Points South:
Take I-95 North to I-495 (Capital Beltway) toward Tyson's Corner/Rockville.  Follow I-495 for 20 miles.  Take Exit 34 (Bethesda/Wisconsin Avenue).  Travel approximately 1 mile and turn right at the light onto South Drive.  Pass through NIH security and follow the signs to Building 45.
 
From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Take the Route 195 connector to I-95 South.  Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring.  Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue).  Follow signs for Route 355 South and stay in the right lane.  Travel approximately 1 mile and turn right at the light onto South Drive.  Pass through NIH security and follow the signs to Building 45.
 
From Washington Dulles International Airport (IAD):
Take the Dulles Access Road for approximately 13 miles to Exit 18.  Move to the right on the Dulles Toll Road (Route 267) and take Exit 18.  Stay left on the ramp for Bethesda/Baltimore, and proceed toward Bethesda (I-495).  Continue approximately 9 miles on I-495.  Stay on I-495 at the I-495/I-270 split (bear right).  Take Exit 34 (Wisconsin Avenue South/Route 355) toward Bethesda.  Travel approximately 1 mile and turn right at the light onto South Drive.  Pass through NIH security and follow the signs to Building 45.
 
From Ronald Reagan Washington National Airport (DCA):
Take the George Washington Parkway North for 12 miles to I-495 toward Maryland (Capital Beltway).  Take Exit 34 (Bethesda/Wisconsin Avenue).  Travel approximately 1 mile and turn right at the light onto South Drive.  Pass through NIH security and follow the signs to Building 45.

PARKING INFORMATION

Parking on the NIH campus is limited and is $12 per day in the visitor lots.

ACCOMMODATIONS:

Bethesda Marriott Hotel
5151 Pooks Hill Road
Bethesda, MD 20814
Phone: (301) 897-9400 OR (800) 266-9432
Website:  http://www.bethesdamarriott.com 
(More hotel information can be obtained from this Website.)
 
A block of sleeping rooms has been reserved at the hotel for arrival on Monday, July 18, 2011, and departure on Wednesday, July 20, 2011. To make a reservation, call (800) 266-9432 and mention the  CKD Workshop Room Block   to obtain the government rate. You may also make your reservation online:
https://resweb.passkey.com/Resweb.do?mode=welcome_ei_new&eventID=3371671 .

The government rate will only be available until   Thursday, July 14th, so please make your reservations as soon as possible.  Please note that reservations must be cancelled no later than 24 hours prior to the scheduled arrival date or you will be charged for 1 night's room and tax. Check-in time is 4:00 p.m., and check-out time is 12:00 p.m.

DRIVING DIRECTIONS

From Points North and East:
Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Turn right at the light onto Pooks Hill Road. The hotel is on the right.
 
From Points North and West:  
Take I-270 South to I-495 East (Capital Beltway) toward Washington, DC. Stay in one of the three left lanes. Follow signs for Route 355 South, a left-lane exit, onto Wisconsin Avenue. Follow signs for Route 355 South and stay in the right lane. Turn right at the light onto Pooks Hill Road. The hotel is on the right.
 
From Points South:
Take I-95 North to I-495 (Capital Beltway) toward Tyson's Corner/Rockville. Follow I-495 for 20 miles.  Take Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane.  Turn right at the light onto Pooks Hill Road. The hotel is on the right.
 
From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Take the Route 195 connector to I-95 South. Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Turn right at the light onto Pooks Hill Road. The hotel is on the right.
 
From Washington Dulles International Airport (IAD):
Take the Dulles Airport Access Road for approximately 13 miles to Exit 18. Move to the right on the Dulles Toll Road (Route 267) and take Exit 18. Stay left on the ramp for Bethesda/Baltimore, and proceed toward Bethesda (I-495). Continue approximately 9 miles on I-495. Stay on I-495 at the I-495/
I-270 split (bear right). Take Exit 34 (Wisconsin Avenue South/Route 355) toward Bethesda. Follow Wisconsin Avenue to the first traffic light and turn right onto Pooks Hill Road. The hotel is on the right. 
 
From Ronald Reagan Washington National Airport (DCA):
Take the George Washington Parkway North for 12 miles to I-495 (Capital Beltway) toward Maryland.  Take Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane.  Turn right at the light onto Pooks Hill Road. The hotel is on the right.

METRORAIL

The Metro system operates from 5:00 a.m. to 12:00 midnight on Monday through Thursday; 5:00 a.m. to 3:00 a.m. on Friday; 7:00 a.m. to 3:00 a.m. on Saturdays; and 7:00 a.m. to 12:00 midnight on Sundays. Each passenger must buy a farecard to travel in the system.  Guides for purchasing farecards are posted on the vending machines in each station. Each Metro car features a complete color-coded map of the system. Station attendants on duty at each station can provide additional information on request. A map of the system is available at: http://www.wmata.com/rail/maps/map.cfm
 
From Union Station or downtown Washington (main Metro Lines into the city converge at Metro Center Station and Gallery Place Station), take the Metro Red Line toward Shady Grove. Exit at the Medical Center Station. The hotel has a shuttle that runs every half hour. Please notify hotel of the pick-up request at the number above.

SHUTTLES

SuperShuttle offers service to most hotels from Ronald Reagan Washington National Airport, Washington Dulles International Airport, and Baltimore/Washington International Thurgood Marshall Airport. The shuttle leaves on an as-needed basis between the hours of 5:30 a.m. and 11:00 p.m. During other times, arrangements for a shuttle can be made by calling (800) 258-3826 from the airport, or by visiting their Web site at http://supershuttle.com
Hotel Shuttle to NIH Campus:  The hotel provides a complimentary shuttle to the NIH Campus that runs every half-hour starting at 6:30 a.m. The shuttle has limited seating and is first-come, first-serve.

TAXIS

The taxi fare is approximately $45-$55 from Ronald Reagan Washington National Airport, approximately $55-$65 from Washington Dulles International Airport, and approximately $65-$75 from Baltimore/Washington International Thurgood Marshall Airport. Fares may differ during peak travel hours.

Minutes

​Minutes are currently unavailable.

Attendees

​Attendees are currently unavailable.

Abstracts

​​Abstracts are currently unavailable.

Location

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  • Natcher Conference Center, NIH Campus
  • MD 20892
Webinar

Contacts

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For questions concerning program content, contact:
Dr. Michael Flessner, NIDDK, NIH
flessnermf@niddk.nih.gov

Dr. Yining Xie, NIDDK, NIH
xieyi@niddk.nih.gov
 
For registration information, contact:
Mary Compton
Conference Planner
The Scientific Consulting Group, Inc.
656 Quince Orchard Road, Suite 210
Gaithersburg, MD 20878-1409
Tel:  (301) 670-4990 x249
Fax:  (301) 670-3815