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Registration

Registration is free and is required for both online and on-site attendance. All interested parties are encouraged to register at Eventbrite.

Summary

The goal of this workshop is to stimulate discussion between the FDA, academicians, and industry representatives on endpoint and trial design to promote drug development in kidney transplantation. The last drug FDA approved for use in prophylaxis of organ rejection in kidney transplant was belatacept in 2011. It is well established that kidney transplantation offers a clear survival and quality of life advantage to patients with end-stage kidney disease. The current treatment options have resulted in excellent short-term graft and patient survival but not without long term side effects. The FDA recognizes the importance of offering safe and effective drugs with a tolerable adverse effect profile to preserve kidney allografts for patients. This workshop aims to discuss current and future endpoints and trial designs that can promote development in this area of unmet needs.

Topics for Discussion

The topics of discussion include efficacy endpoints for prophylaxis of kidney transplant rejection trials:

• Current state of primary endpoints and future potential endpoints.
• BPAR efficacy failure: long term impact, impact of treatment and grade of rejection.
• Non-inferiority Trials: identifying clinically important NI margin, safety and secondary efficacy endpoints.
• Enrichment as a tool in trial design: identifying target populations.

About The Co-Sponsor

The University of Manitoba is a Canadian public research university in the province of Manitoba, and the University of Manitoba Transplant Center (Transplant Manitoba) in Winnipeg is recognized for its scientific research and innovation in kidney transplantation. The first kidney transplant at Transplant Manitoba was performed in 1969, and since then, over 1,700 kidney transplants have been performed by both the Transplant Manitoba adult and pediatric programs. Transplant Manitoba has spearheaded the use of surveillance biopsy following kidney transplantation which has led to its adoption in many countries worldwide, and has published leading research findings in the use of donor-recipient human leukocyte antigen (HLA) eplet mismatch scoring with its impact on kidney transplant outcomes.

Workshop Materials

• Agenda (PDF - 246 KB)
• Final Presentation (PDF - 38 MB)

Visiting the FDA Campus

Entrance for the public workshop participants (non-FDA employees) is through Building 1 and routine security check procedures will be performed. For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.

Virtual Attendance Information

This meeting will be hybrid. The Zoom link will be provided to all registered attendees in a calendar invite the before the meeting.

Food & Drink

Public meeting attendees may bring their own food and drink. However, the FDA cannot guarantee the use of a refrigerator or microwave. Light refreshments and sandwiches are often available for purchase at public meetings. Restaurants near the FDA White Oak campus are available, before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening. 

Accessibility

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before a public meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Contact

For additional details, contact the FDAs CDER/OND/Public Meeting Support Team at ONDPublicMTGSupport@fda.hhs.gov.

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