Patient-Focused Drug Development Meeting on Lupus Nephritis

Researchers looking at a computer together

Please share your perspective on lupus nephritis

If you live with lupus nephritis or are a care partner: please share your experience regarding symptoms, treatments, clinical trials. We may read them at the meeting.

Please share your experience with the disease. This can include your daily symptom burdens, your quality of life, your aspirations for drug therapies and/or your thoughts on clinical trials.

View the Recorded Meeting

 
An exciting opportunity hosted by the National Kidney Foundation for people living with lupus nephritis to share with the U.S. Food and Drug Administration (FDA) and pharmaceutical companies what it’s like to live with this disease.
 
This will be an in-person meeting but online attendance will be possible. The meeting is called an Externally-Led Patient-Focused Drug Development meeting.

Event Details

October 11, 2024 | 10:00am – 3:30pm Eastern Time
College Park Marriott Hotel (Hyattsville, MD) Book by September 19th to receive a discounted room rate ($219/night).
Book your room
 
This will be an in-person meeting. If you prefer to join remotely, the link to the meeting will be posted on this page on the day of the meeting (October 11, 2024).
 
Questions?
 

Voice of the Patient Report

After this meeting, a report titled “Voice of the Patient” will summarize what was heard during the meeting and will serve as a key reference for future Lupus Nephritis drug development efforts. This report can support FDA staff by informing the therapeutic context and can serve as a reference when advising drug sponsors on their development programs. The report will be available for the public to read.

Find Out More

Soon after you register, you will receive an invitation to an Informational Webinar on the EL-PFDD Meeting. This webinar will provide the background so you can participate fully in the meeting.

Register Online

Anyone who lives with or is interested in lupus nephritis is encouraged to attend. This includes people with lupus nephritis of all ages, care partners, families, and friends, as well as physicians, researchers, and other interested individuals.
 
Each person (e.g., child, spouse, etc.) must register separately.
 
Watch this page for updates during week of October 7, 2024:
  • You'll be able to submit comments on your experience with lupus nephritis before the meeting
  • The link to join the meeting will be available on the day of the meeting (October 11, 2024)
Register

Take the patient survey

We need your input on how lupus nephritis has affected your life. We need your input even if you can’t attend the meeting.
 
Your response will help us plan a meeting that will most clearly inform the FDA and Pharma on what it’s like to live with lupus nephritis.
 
Information you provide in the survey will NOT be shared with anyone or any organization.
Take the survey

What are EL-PFDD meetings?

Externally-Led Patient-Focused Drug Development (EL-PFDD) meetings bring together people with lupus nephritis and care partners, FDA representatives, pharmaceutical companies, and doctors and researchers who are experts in the particular disease. For the meeting on lupus nephritis, the goal is to hear from individuals with lupus nephritis what it's like to live with lupus nephritis, so the FDA and pharmaceutical companies can understand the daily challenges, their preferences and hopes about living with this disease. This patient input can help inform FDA’s decision making on potential medicines for lupus nephritis and pharmaceutical companies to design medicines and clinical trials that are meaningful for people living with lupus nephritis.
 

The EL-PFDD meeting on lupus nephritis

  • This meeting will be on Friday, October 11, 2024 from 10:00 AM to about 3:30 PM Eastern Time
  • It will be in-person, with the option to participate remotely.
    Attending in person is best: you’ll be able to interact directly with the other participants and meet others who live with lupus nephritis.
 
The meeting agenda consists of two brief presentations on lupus nephritis by experts in the disease, a presentation by the FDA, patient panels, and extensive audience discussion sessions. The broad discussion topics will focus on your input about:
  1. Living With Lupus Nephritis: Disease Symptoms and Daily Impacts
  2. Clinical Trials in Lupus Nephritis
  3. Current Challenges to Treating Lupus Nephritis
 
The meeting will be co-chaired by two leading physicians who are experts in lupus nephritis:
Dr. Maria Dall’Era
Professor and Chief, Division of Rheumatology
University of California at San Fransisco
Dr. Brad Rovin
Director, Division of Nephrology
Ohio State University Wexner Medical Center
 
Because the FDA wants to hear from only people with lupus nephritis and their care partners, everyone else in the audience will be in “listening mode.”

Why is this meeting important to me?

This EL-PFDD meeting is a unique opportunity for you and your care partners to share experiences with the FDA and the Pharma industry concerning what your daily life is like with lupus nephritis.
 
  1. What are the daily challenges that your symptoms cause?
  2. What do you need in new medicines to make a meaningful difference in your life?
  3. In what type of clinical trial might you be willing to participate?
  4. Many other things the FDA and pharma want to hear so they understand what matters to individuals with lupus nephritis regarding new treatments for the disease.
 
Your input will help the FDA to judge whether new drugs seeking approval meet the needs of people living with lupus nephritis.
 
Pharmaceutical companies can use your input when they develop new treatments and design clinical trials for lupus nephritis.

Hear from Previous Participants

FDA Participant

I can say with certainty…that the stories that you shared with us today, your experiences with the disease will certainly impact how we at FDA will think about this disease, will approach our discussions with sponsors moving forward, and will really shape the development in the future of therapies for this disease.

Patient Participant

Being able to tell my story, be heard, and people empathizing and understanding the struggles this disease faces you with is indescribable.

FDA Participant

I think that your stories really highlight the urgency with which we need to find effective treatments for this disease, and also treatments that have better safety profiles than those that are currently out there.

Patient Participant

I liked that everyone was invited to speak freely and participate. It was an excellent opportunity to tell our stories.

More Important Information

If I take the Patient Survey, what will you do with the information I provide?

The information you provide will remain strictly confidential: it will not be shared with anyone or any organization.
 
The information you provide will remain confidential: it will NOT BE SHARED with anyone or any organization outside of the NKF in a way you can be identified.
 
Your responses will be used to plan the meeting. They may also be included in the Voice of the Patient Report after the meeting or in other educational materials. However, your name and other identifying information WILL ALWAYS BE REMOVED.

Is there a charge to attend the meeting?

No, this meeting is free and open to the public. If you need to stay overnight, you will be responsible for your lodging.

What if I want to attend in person but can’t afford the trip?

We will have a limited number of travel scholarships available on a first – come, first – served basis.

What about meals during the meeting?

There will be a Welcome Reception Dinner the night before the meeting
 
Breakfast and lunch will be provided on the meeting day

How do I register to attend the EL-PFDD meeting?

Click here to register for the meeting. The link to join remotely will be sent before the meeting.
 
EACH PERSON (e.g., CHILD, SPOUSE, ETC.) MUST REGISTER SEPARATELY.

Can my care partner/parent/friend attend the meeting?

YES! Anyone caring for a person with lupus nephritis or interested in the disease is welcome to attend.

When and for how long is the EL-PFDD Meeting on lupus nephritis?

The meeting will be on Friday, October 11, 20242 from 10:00am to about 3:30 Eastern Time

Is this EL-PFDD Meeting on lupus nephritis for pediatric patients?

YES! We want people of all ages living with lupus nephritis to attend.

What happens after the meeting?

NKF will write the Voice of the Patient Report. This will be sent to the FDA and can be used to help in their decisions to approve potential new treatments for lupus nephritis.

The National Kidney Foundation is proud to partner in the planning of this EL-PFDD meeting with the following organizations

Lupus and Allied Diseases Association, Inc.
Help us solve the cruel mystery - Lupus Foundation of America
Lupus Research Alliance - Lupus Therapeutics

The National Kidney Foundation (NKF) is the oldest and largest non-profit health organization dedicated to preventing kidney diseases and improving the health and well-being of individuals and families affected by kidney disease. Education of patients and healthcare providers is a big part of the NKF’s work, and we support kidney patients by providing all sorts of educational materials, programs, and patient services.

Fabry Support & Information Group (FSIG)

National Kidney Foundation

The National Kidney Foundation (NKF) is the oldest and largest non-profit health organization dedicated to preventing kidney diseases and improving the health and well-being of individuals and families affected by kidney disease. Education of patients and healthcare providers is a big part of the NKF’s work, and we support kidney patients by providing all sorts of educational materials, programs, and patient services.