Success! New Kidney Disease Funding

By Troy Zimmerman, Vice President of Government Relations

Each year, the National Kidney Foundation, our allies, and our supporters advocate for increased funding for kidney disease research and programs in Congress.  We are proud to tell you that the work of the kidney disease community has paid off again this year!

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On September 28th, President Trump signed the FY2019 Labor, Health and Human Services and Education appropriations bill, which maintained or increased funding for several priorities for our community.  It increased funding for:

  • The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) by $59 million to $2 billion;

And maintained FY2018 funding for:

  • The Centers for Disease Control and Prevention’s (CDC) Chronic Kidney Disease Program at $2.5 million;
  • The Department of Health and Human Services Million Hearts Initiative at $4 million;
  • The Health Resources and Services Administration’s (HRSA) Bureau of Primary Care at $1.627 billion; and
  • HRSA’s Division of Transplantation at $25.5 million.

If you would like to show Congress the appreciation of the kidney disease community, please consider writing your legislators!

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Patients Engage in FDA Meeting to Spur Drug Development in Transplantation

By: Kelli Collins, VP Patient Engagement and Tonya Saffer, VP Health Policy

On September 27th and 28th the National Kidney Foundation Kidney Advocacy Committee Members participated in the Food and Drug Administration (FDA) meeting, “Evidence-Based Treatment Decisions in Transplantation: The Right Dose & Regimen for the Right Patient/Individualized Treatment”.

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Left to right: Shanon Woodward, Kelli Collins, Haley Newkirk, Brandy Webster, Alex Barrios

Kidney Advocacy Committee members Alex Berrios, Brandy Webster, and Haley Newkirk provided the patient perspective presenting as part of a panel entitled:  The Patient Perspective on their Organ, Treatment and Hopes for Future Management (changes, improvements). 

The National Kidney Foundation has collaborated with the FDA to bring the patient voice to the table for the past several years and is encouraged to see FDA continue to prioritize patient engagement in the process of drug development.

This year, NKF’s kidney transplant recipient advocates, along with two lung recipients, shared their individual experiences and challenges with transplant, side effects, and immunosuppressant medication.  “I enjoyed being able to be a voice at the table, speaking on behalf of my fellow kidney transplant recipients, so that those in charge of drug development hear directly from the people the drug is intended to help. I also enjoyed learning about the upcoming adherence tools that are being discussed,” Alex Berrios.

After presenting their individual experiences, patients engaged in an open panel and Q&A session.  Each recipient’s story was unique but also shared many common threads.  All were incredibly grateful for how a kidney transplant changed their life for the better.  Each patient struggled with side effects and complications to varying degrees.  Some common side effects of the immunosuppressant medication were insomnia, skin cancer, cognitive or memory changes, and weight gain.  They also shared challenges with adherence and high cost of medications.

“As a patient, I learned a lot more about how the drug development process works and how the research and development challenges in the organ transplantation field may affect my care,“ Haley Newkirk says, “I hope that the conversations among patients, regulators, physicians, and researchers will lead to better and more individualized treatments in the future.”

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Left to right: Alex Barrios, Brandy Webster, Haley Newkirk, Shanon Woodward

Also, in attendance was National Kidney Foundation board member and transplant surgeon Matthew Cooper, MD. The meeting was the result of a Public-Private Partnership created in April 2017 and founded by the American Society of Transplantation, the American Society of Transplant Surgeons, the Critical Path Institute and the FDA.

“The Transplant Therapeutics Consortium and the meeting today are shining examples of how the FDA and stakeholders in transplant, especially our patients, are coming together and appreciating we all have a common goal in developing safe and innovative medications and interventions to expand opportunities for transplantation as well as increase the life years gained for those fortunate to receive the Gift of Life,” said Dr. Cooper.

Longtime National Kidney Foundation volunteer and prominent epidemiologist Josef Coresh, MD shared research and findings from a multi-year meta-analysis that examined the largest compilation of data ever collected on chronic kidney disease (CKD), first presented at a workshop hosted by the National Kidney Foundation in March 2018. The joint workshop held with the FDA, European Medicines Agency (EMA) and NKF examined how measuring biomarkers could expedite clinical trials and spur innovation in delaying or preventing progression.  Dr. Coresh shared this data and discussion at the FDA meeting as it may also have applications to developing drugs targeted at preventing transplant rejection.

This FDA meeting highlighted the importance and critical need for innovation in transplant and brought together clinical, research, and patient expertise to help achieve the goal of better treatments for those living with kidney disease.  The National Kidney Foundation is grateful for the work that AST, ASTS, C-Path and the FDA are doing to spur new drug development in transplantation. The input and perspective of transplant recipients was central to the discussion and will be used to further efforts to align drug development with goals that are most important to patients.

Share your experience as a transplant recipient with the FDA. Send comments via this link:  https://www.regulations.gov/document?D=FDA-2018-N-3010-0001 and click Comment Now!   Comment period will be open until November 19th.

Learn more about the conference and watch a recording of the webinar here: https://www.fda.gov/Drugs/NewsEvents/ucm605761.htm

Related information: 

Conference on End Points in Clinical

Organ recipients share their experiences with FDA to promote innovation in immunosuppressive therapies 2016 Meeting

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Job Security for Living Organ Donation Guaranteed Under FMLA!

By Kevin Longino, CEO of the National Kidney Foundation and kidney transplant recipient

I am delighted to share wonderful news with the kidney disease community.

On August 28th, the U.S. Department of Labor issued an opinion letter on living organ donation which protects the job security of living donors who are eligible under the Family and Medical Leave Act (FMLA). This important clarification ensures that eligible employees who seek to use time off to donate an organ to help save another’s life are entitled to unpaid, job-protected leave.

This clarification was a direct result of efforts by Representative Jaime Herrera Beutler (R-WA) through her work on the House Appropriations Committee.  Working with the National Kidney Foundation, Rep. Herrera Beutler developed language that was included in the Committee Report to the Fiscal Year 2019 Appropriations Bill for the Departments of Labor, Health and Human Services, Education and Related Agencies.  The Report Language directed the Department of Labor to issue a clarification on FMLA for living donation.

We thank Rep. Herrera Beutler for making this  possible. While this is a huge victory for patients and organ donors, we need to keep advocating for the Living Donor Protection Act (H.R. 1270) to provide protection from discrimination in the pricing or availability of life, disability or long-term care insurance.   Please write (or tweet) your federal legislators today, if you have not already done so, to ask them to become a co-sponsor of H.R. 1270.

1For more information on FLMA visit the U.S. Department of Labor website.
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Three weeks to speak to your legislators

By Andrew Fullerton, National Kidney Foundation

Throughout the year, many of our readers have been invaluable advocates by writing, tweeting and calling your legislators in support of the Living Donor Protection Act; H.R. 3867, legislation to promote the early detection and treatment of kidney disease; and other state-specific legislation.  This August, we ask you to join many of your fellow advocates who have met with their Members of Congress and make another step forward for kidney patients.

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Left to Right: David Salomon, Sara Booth, John Hyde, Gail Salomon, Congressman Lance, Judy Rosenstein, Abe Rosenstein and Meg Gilmartin

During the next three weeks, your legislators will continue to be home meeting with their constituents; this mean you!  While they are in your hometowns speaking at town halls, meeting with civic organizations, and attending county fairs and parades take this opportunity to speak to them.  You can reinforce the message we share with legislators by telling them about your kidney disease story and that they need to support kidney patients in Congress!  Linking your story and your face to kidney disease in their minds can make all the difference.  If you need assistance, materials or to report a meeting with your legislators, email me at nkfadvocacy@kidney.org!

Thank you for your continued support in making advances to kidney disease policy possible.

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A Patient Perspective on Bayer Pharmaceutical’s First Clinical Trial Patient Retention Summit

By Cari Maxwell, Kidney Advocacy Committee member

It was my privilege to be a guest speaker at Bayer Pharmaceuticals’ first Clinical Trial Patient Retention Summit in June 2018 near their headquarters in New Jersey. Bayer is constantly engaged in new research, with the hopes of developing additional treatment for patients that are managing various healthcare conditions. Embracing a patient-centric approach to disease research, the pharmaceutical company conducted a training meeting for their US and Canadian teams on two of their current research programs in Diabetic Kidney Disease, which hope to delay disease progression in patients at risk of losing their kidney function due to their history of diabetes and also demonstrate a risk reduction for cardiovascular events.

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Through my role on the NKF Patient Advocacy Council, I met with Bayer’s clinical team to share my personal experience participating in a non-Bayer clinical drug trial yet also connected with kidney disease. Bayer saw the value in having an actual patient that had participated in a long-term trial speak to the group on what it is like to be a clinical trial patient. Their strong desire to help the rest of the Bayer team understand and reflect on the experiences of clinical trial participants was evidenced by the significant focus of the Summit specifically on patient retention means and methods.

In my time addressing the team, I placed a significant emphasis on trial leaders helping trial participants understand their role in the health community at large. When a patient enters a clinical trial program it can be overwhelming between the lengthy informed consents, getting adjusted to a new medication, and managing the frequency of in-clinic visits. When my own trial drug gained its FDA approval in April of this year, I received a lot of positive feedback, congratulations, and even sincere appreciation from patients and caregivers alike. I admitted to the Bayer team that it wasn’t until this approval and what followed for me personally that I realized I had a significant part in doing for others what they could not do for themselves. While I knew there was greater impact beyond my own health and the potential for others in the future to receive the drug, the FDA approval brought that more into focus. From a retention perspective, helping patients understand the critical role they play in a clinical trial may help retain those patients who could be on the fence about ending their study participation before a study is completed, and could help get those patients through difficult moments in their trial participation

In the end, it was a most rewarding experience to share my passion for clinical research, and to have the opportunity to talk about my own health journey. For me, my health story is incomplete without finding ways to turn my challenges into positive outcomes for myself and others. It was a great collaborative experience and I am glad I could contribute to the Retention Summit to help advocate for patient–centric approaches.  Seeing patients’ needs being placed at the forefront of pharmaceutical industry decision-making is to be applauded, and I look forward to continuing the conversation in the pharma community to further enhance the patient experience.

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Volunteering With The Local NKF Office On A Walk

By Curtis Warfield, Kidney Advocacy Committee member and transplant recipient

The National Kidney Foundation’s Kidney Walk is an important event in every community that is fortunate to host one.  Not only does it raise funds for research programs; it also brings awareness and education to participants and the general public and supports the kidney patient community. I participated in my first Kidney Walk with my family and donor two years ago (2016) when I was six months post-transplant. Last year, I stepped it up a bit and captained my own team with team shirts and the works.

While our Walk in Indianapolis has been well attended and an overall amazing event, I felt something was missing.  Other major walks and runs hosted in the city have had a local or national celebrity – the mayor, governor, or some other high ranking public official – to help promote and open the event. This brought additional hype, press coverage and awareness for that event. I wanted to help bring this type of awareness for the Indianapolis Kidney Walk.

I contacted Margie Evans Fort, CEO of the NKF of Indiana, and asked if there was anything I could do to assist their office in soliciting this support from local officials. I informed her of my ideas and willingness to help. Margie was quick to say yes and offer her support as I started working towards this goal getting a local legislator to speak at the Walk.  I also requested a table at the Walk to have information on the legislative priorities, including the Living Donor Protection Act(H.R. 1270) & H.R. 3867 promoting early detection and treatment of kidney disease, letters for walkers to sign for their legislators and other information from the local office.

Additionally, I contacted my Kidney Advocacy Committee (KAC) Regional Leader and fellow Hoosier, Jim Myers, to inform him of my plans and bounce ideas off him. Jim, as always, was very supportive.

I had two main goals in mind as I embarked on this journey to engage our local leaders:

  1. Have several officials attend as speakers with their staff
  2. Have an Indianapolis Kidney Walk Day proclamation presented at the Walk.

To begin, I made of list of officials that included my congressman, neighboring congresswoman whose district covers the north part of the city, our two U.S. Senators, Governor, Mayor and the State Health Commissioner.  Then, I contacted the mayor’s office by phone to inquire about getting a proclamation. It wasn’t a difficult process. I had to included facts about the Walk, kidney disease, how many people are affected in the local area, and what the local office is doing to promote and bring awareness to kidney disease. After reviewing the materials submitted to the mayor’s office, the mayor granted a proclamation for Indianapolis Kidney Walk Day.

Next, I used contacts built through my involvement with KAC and official websites to reach out to the other elected officials on my list.  In each invitation, I included the details of the Walk, how the Walk affects the local community and how their appearance would be supportive to the kidney community. While most responded with a conflict of schedule and could not attend, several sent letters of support to be read at the Walk.

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Sen. Donnelly (D-IN) and Curtis Warfield

One elected official, U.S. Sen. Joe Donnelly (D-IN) originally wasn’t going to be able to attend; but asked to have a senior staff member in his place with his statement. Fortunately, four days prior to the Walk I received a message from Sen. Donnelly’s office that they had changed his schedule to allow him to join us at the event.  I was honored to serve as NKF’s contact person for the Senator on Walk Day.

We scheduled Sen. Donnelly to conclude the opening ceremony so I would could speak to him and leave some information with him and his team. With the help from the NKF Government Relation Team, I put together a package for the Senator that included information about the Living Donor Protection Act, H.R. 3867 and appropriations funding requests.

When he arrived, I greeted him and brought him to the stage before I made my remarks as a representative for KAC on our legislative efforts for the kidney patient community. The Senator gave his remarks, kicked off the Walk and greeted each of the walkers as they started on the route.  I was fortunate to also have my kidney donor with me, so I introduced her as I spoke with the Senator about the need to protect our living organ donors.  This caught his interest and he stayed to speak with her about living donation.

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The Walk was a wild success.  The Walk participants were excited to have one of their top legislators there and the local office was very excited to have the Mayor’s office proclaim Indianapolis Kidney Walk Day. The news coverage opened the Walk up to a broader audience. The Senator was able to get out and meet constituents with kidney disease. Also, I had another chance to meet with the Senator and his staff to remind him about our community’s policy needs.

Having our public officials appear at the Walk can bring greater awareness to the Kidney Walk and our local NKF offices. This expands NKF’s presence in our community and public officials are exposed to the kidney community, able to mingle with their constituents, and ultimately put faces with to kidney disease and hear their stories.  It also supports our efforts as KAC members to advocate for kidney disease policy and educate our legislators.

I am excited to share I have even been invited to be on next year’s Walk committee. I’m looking forward to building on this year’s success. Volunteering with the local NKF office has helped strengthen my relationship with them and improve the Walk.  I look forward to further improving this relationship, working with them on future projects and being able to support each other for the causes of kidney awareness, education, research, funding and policy advocacy.

 

 

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NKF Peers: Successful Model of Patient Engagement

By, Kelli Collins, MSW Vice President, Patient Engagement, National Kidney Foundation

The National Kidney Foundation was invited to Institute for Patient and Family Centered Care (IPFCC) 8th Annual International Conference to present on its signature Peer Mentoring program. We were honored to have our session, “Successful National Telephonic Peer Mentor Program: Review of National Kidney Foundation’s Peer Program,” chosen as the Celeste Castillo Lee Leadership Lecture at the conference in Baltimore in June.

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IPFCC aims to advance the understanding and practice of patient and family centered care and seeks to integrate these concepts into all aspects of healthcare in partnership with patients, families and healthcare professionals.  Celeste Castillo Lee was the chair of NKF’s Patient and Family Council for many years and also worked closely with IPFCC.   As a pioneer in demanding patient centered care and patient engagement, Celeste inspired much-needed change through her steadfast commitment and tireless efforts to advance the level of patient engagement.

Our session illustrated how our intuitive platform successfully supports patients by matching them with mentors who are inspiring their mentees to live well on dialysis and/or work towards ending their wait for a transplant.  My co-presenters were Risa Simon, NKF Peer Mentor and Advocate and founder of the TransplantFirst Academy, and Ashwin Patel, MD, PhD and Chief Medical Officer of InquisitHealth, our technology partner.  InquisitHealth technology allows us to match and connect pairs via a toll-free phone system as well as to track participation.  NKF’s Peers program has been successfully supporting patients since 2011 and continues to grow.  To date, NKF Peers has matched over 700 people seeking support with a peer mentor.

“The PeerStrong technology platform has the privilege of serving the NKF Peers Program – helping the program expand and scale, while producing tremendous improvements in the PAM, or Patient Activation Measure, scores for patients with chronic kidney disease,” shared Dr. Patel. “We are working together to connect the dots between peer support and measurable improvements in clinical outcomes.”

NKF Peers mentor, Risa Simon shared her experience as a mentee and mentor. “Most patients don’t realize that there is a world of support outside the walls of their doctor’s exam room. After informally discovering this hidden gem back in 2008, I looked for ways to pay it forward. When I learned of NKF’s Peers program I applied without hesitation. Since its inception, I’ve been sharing top notes from my journey with the goal of inspiring self-advocacy for better outcomes. It’s an honor and privilege to serve NKF’s kidney patient community in the spirit of hope to a better tomorrow.”

While attending other sessions at the conference, I learned how other healthcare groups were implementing best practices in patient engagement.  As a social worker I have always advocated for patients and family members and worked to empower patients to be their own best advocates.  In healthcare, it is wonderful to see that patient engagement is taking center stage — that the patients’ needs and experience are getting the attention they deserve.  Although great strides are being made, there is still work to do. The reality is, the ideal patient-centric experience is not the norm for most. However, conferences like these, where professionals and patients come together to share their experiences and best practices are invaluable to driving change forward.

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Reflections on my Experience at the Building Research Capacity in the Dialysis Community at the Local Level Workshop

By David White, Kidney Advocacy Committee member

The “Building Research Capacity in the Dialysis Community at the Local Level” workshop was the first of its kind to focus exclusively on improving the research capacity of dialysis clinics. The workshop, funded by a Eugene Washington Patient-Centered Outcomes Research Institute (PCORI) Engagement Award, brought together patients, care partners, clinic staff members, medical providers, corporate dialysis organization representatives, and researchers to discuss the benefits and realities of incorporating research into routine dialysis care delivery and identify facilitators of and barriers to performing real-world research in local dialysis clinics.

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As a former in-center hemodialysis patient, my biggest takeaways were learning that there is a huge difference between the number of dialysis patients who are interested in research and the number who actually participate in research and that the biggest reason they want to participate is to help prevent others from developing kidney disease (many thanks to Derek Forfang for sharing this information with the workshop participants during a very informative presentation and panel discussion).

Just as clinicians should embrace the concept of patient-centered care, researchers and contracted research organizations should be encouraged to make dialysis clinics full partners in any research project that their patients are engaged in. Everyone from clinic leadership to the nurses, techs, patients and families, security personnel, and even transportation providers should have the opportunity to feel like a partner in research; when all contributions are valued and celebrated, any initiative will become easier to execute.

Tavon Sumler, a dialysis patient care technician, shared a great insight as to why he found integrating research into his daily work challenging: he often would have to take a few extra minutes to find the required materials. A few minutes in a dialysis clinic can mean the difference between life and death. I watched clinic staff work for five years and can attest that they have a lot to do and not a lot of time to do it – even before asking them to add clinical trial tasks to their duties.

My personal experience with clinical trials illustrates how relationships are key to conducting effective research in dialysis clinics. I chose to participate in one clinical trial my clinic offered because I was approached by my nurse practitioner, a person I knew and trusted. She explained the purpose of study to me and how the study would be conducted, and emphasized that I could end my participation at any time. Once I agreed to participate, the next step was introducing me to my researcher contact, and she made the introduction personally (I learned during the workshop that this is called a “warm handoff”).

I had another opportunity to participate in clinical trial in the same clinic, and I was not the least bit impressed by the researcher’s attempt to engage with me. I was sitting comfortably during my dialysis “run” one afternoon when a person I had never seen before walked up to my station and asked if I would be interested in being a study participant. My very first thought was “why did you walk up to me – there are two dozen people sitting in chairs,” and that’s exactly what I asked her. She told me that she had been told that I would be a good candidate, but her explanation was even more off-putting than her uninvited approach; it felt like she would rather talk to the clipboard she was holding than to me. I responded by telling her that I was not interested, but it would have been more accurate to say that I was not interested in her or that I was not interested in the study at that time. We both left the encounter disappointed. Mind you, this happened at the very same clinic; if there was a general protocol in place for approaching potential study participants (or a protocol that was already in place was followed), I may very well have responded more positively.

Some lessons learned from this encounter that might be helpful to researchers are:

  • I was never informed that someone would be approaching me to see if I might be interested in being a study participant – either before that day or at the beginning of my dialysis shift. Had I been approached in advance, I would have been more likely to participate;
  • The person who approached me had poor communication skills. Researchers should practice their approach before engaging with patients;
  • No one at the clinic or the research facility ever followed up with me to see why I wasn’t interested. By following up they may learn something to help the next time around and

Communication is a key ingredient to a successful research environment and is one of the biggest stumbling blocks to building research capacity in dialysis clinics.   I recommend that every proposal to conduct research in a dialysis clinic setting include a training component that emphasizes communication skills, cultural humility, and seamless integration of research tasks into the clinic’s workflow.

 

 

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Congressional Action to Support Living Organ Donation in the Family and Medical Leave Act

Today, we announce a significant win with the removal of a barrier to living organ donation! The National Kidney Foundation worked closely with Rep. Jaime Herrera Beutler (R-WA) to develop language to protect living donors’ jobs that will be included in the Committee Report to the Fiscal Year 2019 Appropriations Bill for the Departments of Labor, Health and Human Services, Education and Related Agencies.

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The provision in the Committee Report requests the Department of Labor to give notice on its website or in other public communications that living donors who are qualified for the Family and Medical Leave Act (FMLA) are eligible for family medical leave when they donate an organ.  This means that if the Department of Labor makes the requested notification, living donors who take time off for surgery and recovery will have their jobs guaranteed when they return to work, which is a big concern for living donors.

We would like to thank Congresswoman Jaime Herrera Beutler for making this achievement possible. However, while this is a huge victory for patients and organ donors, we need to keep pressing Congress to pass the Living Donor Protection Act (H.R. 1270) which also provides protection from discrimination in the pricing or availability of life, disability or long-term care insurance.   Please write them today, if you have not already done so, to ask them to become a co-sponsor of H.R. 1270.

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Florida State Legislators Making Footprints in the Sand at the Cocoa Beach Kidney Walk

By Bill Hahn, Kidney Advocacy Committee member and kidney transplant recipient

On Saturday May 12th, 2018, the National Kidney Foundation of Florida (NKFF) held its 7th Annual Cocoa Beach Footprints in the Sand Kidney Walk. Congressman Bill Posey, our honorary walk chair, and State Senator Debbie Mayfield joined hundreds of patients, donors, recipients and volunteers to celebrate the gift of life though organ, tissue and eye donation.

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2018 Cocoa Beach Footprints in the Sand Kidney Walk
https://www.facebook.com/npiproductions/videos/1909841512367596/

“Raising awareness is a key component to combating kidney disease and ultimately saving lives. So many of us have family, friends and loved ones who are fighting this disease and they need our strength and support. The road ahead may not be easy for them, but as the Kidney Walk demonstrates, they do not have to travel that path alone.” said Congressman Bill Posey.

As part of our “Celebration of Life” weekend, we saluted Florida’s living kidney donors 3x7_LivingDonorsDay_Banner.jpgwith a Living Kidney Donor Day proclamation. This was our second annual tribute to these selfless heroes who share the gift of life. Living kidney donation is the most successful treatment we currently have in extended life and providing the chronically ill a better quality of life.

We also took the opportunity to advocate for protecting our living kidney donors through the Living Donor Protection Act (H.R. 1270).  The Living Donor Protection Act is a common-sense bill that will make it easier for donors to give the gift of life to those in need by ensuring job security through the Family and Medical Leave Act and ending certain forms of insurance discrimination that living donors often face. Sometimes making small changes in the law can make a big difference in people’s lives!

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The Footprints in the Sand Kidney Walk also honored deceased donors’ moms on Mother’s Day weekend. We dined and walked together on a beach full of life. We celebrated our heroes. Congressman Posey presented a Congressional Certificate of Recognition to honor the mothers of organ donors. He also submitted a Congressional Record statement to celebrate these donor moms and the ultimate gift of life provided by their child. Thank you, Congressman Posey, for providing this congressional tribute for our donor moms. Many of these incredible women have been advocating for the gift of life for decades and this act will help give them a measure of closure for their loss.

What will you do to honor our kidney donors?  Volunteer and support the National Kidney Foundation at an upcoming event?  Become an advocate by writing your legislators on important policy initiatives supporting kidney patients and donors?

See our video of the 2018 Cocoa Beach Kidney Walk:

https://www.facebook.com/npiproductions/videos/1909841512367596/

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