Antibody Mediated Rejection in Kidney Transplantation; Public Workshop

The Food and Drug Administration (FDA) is announcing a public workshop regarding new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. This public workshop is intended to provide information for and gain perspective from individuals, industry, health care professionals, researchers, public health organizations, patients, patient care providers, and other interested persons on various aspects of clinical development of medical products for prophylaxis and/or treatment of AMR in kidney transplant recipients, including clinical trial design and endpoints. The input from this public workshop will also help in developing topics for future discussion.

Dates and Times:

April 12, 2017, from 8 a.m. to 6 p.m. Eastern Time and April 13, 2017, from 8:30 a.m. to 1:30 p.m. Eastern Time

Location:

Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903.

The workshop will take place in Ballroom AB, located on the 2nd floor

Registration:

Registration is free. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) by April 6, 2017 to AntibodyMediatedRejectionWorkshop2017@fda.hhs.gov. Registrants will receive email confirmation when they have been registered. Persons without access to the Internet can call 301-796-1300 to register. Onsite registration on the day of the meeting will be provided based on space availability.

Requests for Oral Presentations:

During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation. All requests to make oral presentations must be received no later than April 6, 2017. FDA will review all requests and will determine the amount of time allotted to each presenter and the approximate time each presentation is to begin. Participants will be notified of their selection on or before April 7, 2017. If selected for presentation, any presentation materials must be emailed to AntibodyMediatedRejectionWorkshop2017@fda.hhs.gov no later than April 10, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Contact:

If further information is needed, please contact Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.

Meeting Materials:

The agenda, speaker slides and other meeting material will be posted and/or updated here prior to the workshop. Please note that only printed copies of the agenda, affiliations and disclosures will be provided during the meeting. Please print/bring your own slides, as these will not be provided on the day of the meeting as printed copies.

• Agenda (PDF - 68KB)
• Affiliations and Disclosures (PDF - 21KB)
• Presentations (Day 1)
  • Antibody Mediated Rejection in Kidney Transplantation - Renata Albrecht, MD (PDF - 289KB)
  • New Developments in Kidney Transplantation In the Current Decade - Roslyn B. Mannon, MD (PDF -3MB)
  • A New Paradigm - Peter Nickerson, MD (PDF - 3.67MB)
  • The Relationship Between Acute AMR and Chronic AMR? Do Acute and Chronic AMR Represent a Continuum? - Robert B. Colvin, MD (PDF - 2MB)
  • Impact of Acute and Chronic AMR on Graft and Patient Survival - Peter Nickerson, MD (PDF - 1MB)
  • The Utility of Protocol Biopsies in the Follow-up of Acute AMR and in the Detection of Chronic AMR - Mark D. Stegall, MD (PDF - 2MB)
  • Scientific Aspects; a General Overview of the Currently Used Antibody Measurement Methods, Issues of Standardization, Validation - Speaker: Howard M. Gebel, PhD (PDF - 2MB)
  • Consideration of Quantitative Use of HLA Antibody Assays and a Summary of the 2017 AST/ASHI Antibodies in Transplantation Consensus Conference - Anat Roitberg-Tambur, DMD, PhD (PDF - 2MB)
  • Highly Sensitized Transplant Candidate – An overview - Speaker: Arjang Djamali, M.D. (PDF - 2MB)
  • Recognized and Unrecognized Sensitization: Assessment of the Pretransplant Immunologic Memory and Its Importance (with reference to the 2017 AST/ASHI Antibodies in Transplantation Consensus Conference) - Howard Gebel, PhD (PDF -  2MB)
  • Prevention of Sensitization: Blood Transfusions, Nonadherence during the Previous Transplant and the Management of the failed graft - Robert Gaston, MD (PDF - 733KB)
  • New Developments in Desensitization Protocols. Is there a Standard of Care? - Robert A. Montgomery, MD, DPhil (PDF - 1MB)
  • The Choice of Induction / Maintenance Immunosuppression and their Impact on Preexisting and De Novo Antibodies - Millie Samaniego, MD, FACP, FASN, FAST (PDF - 9MB)
  • Calcineurin Inhibitor (CNI) and Corticosteroid Minimization/Avoidance Protocols and HLA Antibodies - Arthur Matas, MD (PDF - 1MB)
  • Nonadherence – Definitions, Monitoring, Prevention/Management - Rita Alloway, PharmD (PDF - 1MB)
  • The Role of Acute Cellular Rejection Episodes in the Development of HLA Antibodies - Robert S. Gaston, MD (PDF - 1MB)
•  Presentations (Day 2)
  • Monitoring of kidney function and its temporal association with antibody mediated graft damage - Chris Wiebe, MD (PDF - 1MB)
  • Best Way to Assess Renal Functional Status: The Importance of Renal Functional Reserve, Glomerular and Tubular Stress Tests and their Potential Utility in Kidney Transplant Recipients - Lakhmir Chawla MD - (PDF - 2MB)
  • Diagnosis of Acute and Chronic Antibody-Mediated Rejection: Banff Classification and Pathologic Correlates of Graft Survival - Mark Haas, MD, PhD (PDF - 4MB)
  • Diagnosis of Acute and Chronic AMR: Molecular diagnosis and Correlation with Histology and Banff Classification - Speaker: Mark Haas, MD, PhD (PDF - 987KB)
  • Treatment of AMR, Updates since 2010, Standard of Care, emerging therapies? - E. Steve Woodle, MD (PDF - 6MB)
  • Public Comment and Discussion - Robert N. Woodward, PhD (PDF - 438KB)
  • Potential Primary Endpoints in Clinical Trials of Antibody-Mediated Rejection - Gregory Knoll, MD (PDF - 3MB)
  • How to Perform Clinical Studies in Low Incidence Disease/Condition - Collaborative Clinical Studies, Pros and Cons of Composite Endpoints - William Irish PhD (PDF - 631KB)
  • Animal Models in AMR, How Can They Inform Clinical Studies - Anita S. Chong, PhD (PDF - 2MB)
  • Animal Models in AMR (Presensitized Recipient Models) - Stuart J. Knechtle MD (PDF - 795KB)

Meeting Call-In:

In order to listen to the workshop remotely and follow along with the slides being presented, please use the following information below:

To join this meeting

1. Go to https://fda.webex.com/fda/j.php?MTID=m3ce357a7e7eab2b88e8e53e85f325236

2. If requested, enter your name and email address.

3. If a password is required, enter the meeting password: 123456

4. Click "Join".

5. Follow the instructions that appear on your screen.

Teleconference information

1. Provide your number when you join the meeting to receive a call back. Alternatively, you can call one of the following numbers:

Local: 1-301-796-7777

toll free: 1-855-828-1770

2. Follow the instructions that you hear on the phone.

Your Cisco Unified Meeting Place meeting ID: 741 295 076

Please test your WebEx capability prior to the start of the workshop. Please also remember to mute your phones during the meeting.

Transcripts:

• Transcript: Wednesday, April 12, 2017 (PDF - 1MB)
• Transcript, Thursday, April 13, 2017 (PDF - 933KB)