KING OF PRUSSIA, PA (June 23, 2020) – NephCure Kidney International® announced today the promotion of Lauren Lee to Executive Vice President, Stakeholder Engagement, effective immediately. In her new role, Lee will oversee the departments of Research & Engagement, Community Development, and Operations. Lee will continue to report to NephCure Chief Executive Officer Joshua Tarnoff.

Lauren Lee, Executive Vice President, Stakeholder Engagement

In her prior role as Chief Research Officer, Lee transformed the Department of Research & Engagement to reach a broad array of stakeholders, including patients, healthcare providers, researchers, government entities, biopharmaceutical companies, and other like-minded NGOs. She recently led the mission-critical Gateway Initiative that now involves nearly 30 primary glomerular kidney disease clinical trials across the globe and balances a wide number of collaborators. To date, no company has left the space due to recruiting difficulties: the hallmark charge and success gauge of the initiative.

“From day one, Lauren has displayed incredible compassion for patients and tireless dedication to our mission while handling multiple consuming programs,” Tarnoff said. “Her strong leadership and strategic vision in adapting to evolving environmental demands and driving key programmatic successes made her the clear choice both internally and externally when considering candidates for this large and critical new senior level role. I’m thrilled to announce her promotion at a time when our patient community is in urgent need of additional support due to COVID-19 and an influx of clinical research opportunities.”

Lee has worked for NephCure since 2013, starting as Director of Grassroots Operations before spending 6 years directing the Research & Engagement Department. For many years, she led NephCure’s efforts to build a nation-wide network of patient families, clinicians, and researchers, over the years traveling to nearly every major and minor city within the NephCure community. More recently, she has played a key role in effectively steering NephCure into a powerful clinical research facilitator and collaborator within the glomerular kidney disease space.

“It is truly a privilege to be part of an outstanding organization like NephCure,” Lee shared. “We have only just begun to hit our stride in making a material difference in the lives of the patients we serve through meaningful initiatives like Gateway, the NephCure Specialist directory, and our Regional Volunteer Communities. In this new role, I hope to continue the momentum with a keen focus on mobilizing all stakeholders around our mission of bringing new treatments to patients.”

Lee earned a Bachelor of Arts in Anthropology and French from Carleton University in Ontario, Canada and a Master of Arts in Museum Studies from the State University of New York at Oneonta. She will remain based in the Philadelphia area.

About NephCure Kidney International

NephCure Kidney International’s mission is to accelerate research for effective treatments for rare forms of Nephrotic Syndrome, and to provide education and support that will improve the lives of those affected by these protein-spilling kidney diseases. Founded in 2000 by a group of committed patient parents, NephCure has invested more than $40 million in kidney disease research and helped create a landscape where there are now nearly 30 interventional drug trials for primary glomerular kidney diseases. NephCure is a U.S. tax exempt 501(c)(3) public charity.

www.NephCure.org

Contact: Lauren Eva

610-540-0186 x21

Lauren.Eva@NephCure.org

“At 14, I had just finished my first year of high school. I played varsity soccer as a freshman, and I was getting ready for one of the most important summers of my young soccer career. But my life took a different course, and from ages 14-24, I had to completely focus on my health. After my first blood draw–I received my diagnosis of FSGS.

During those initial years with FSGS, I did multiple different treatments, including high-dose IV steroids and chemotherapy. I’ve had two kidney transplants and had both my native kidneys removed. I had a staph infection that caused my first kidney to fail, and I have done a total of 4 years of different kinds of dialysis, as well as at least 20 other procedures. Through that time, managing my chronic kidney illness as part of everyday life, my family wondered, “How are you handling this so well?” I would unknowingly shrug and give a cliché line about needing to move on to the next thing.

Two years later, after numerous treatments and six months of dialysis, I received my first transplant. By 21, my body had rejected the kidney, and after three and half years on dialysis, I received my second kidney at 24 from a family member. I was a rock–in survival mode–for those ten years. Nothing fazed me. In times of pain or frustration, I would be upset but subdued. Once those moments would pass, so would the thoughts about them. It always looked and felt like I was doing great, and I was so strong that not even this illness was going to weigh on me.

Everyone’s perception of me was that I was handling this difficult part of my life well. I didn’t realize until about a year ago that the pain, although I wasn’t thinking about it, was still affecting me.

Jeremy and his kidney donor.

Three and a half months after my second transplant, I traveled for the first time in four years without a dialysis machine. I was ecstatic! My brother was playing in his first away college soccer game for Sacramento State, and I was going to get to see him play. For my brain, it was the first quiet moment it had in my adult life. I was sitting in my friend’s bedroom in LA the day before the game, and nobody was home. I couldn’t stop thinking about the pain of my second transplant. I felt trapped.

Then, as I sat on the bed with my legs stretched out and a blanket over them, TV in front of me, the way I had in the hospital, the bedroom seemingly turned into a hospital room; the house became the 8^th floor transplant ward at UC Davis. I stayed in this state for almost eight hours until my friend walked in the door. I was numb. I had relived the entire day in a hospital room. I now realize that this was my first time experiencing severe Post-Traumatic Stress Disorder symptoms.

This incident confused me, and when I got back home, I started to do some research. It didn’t take long to find out that post-transplant patients, while having lower rates of depression than pre-transplant patients, have significantly higher rates of depression than the general population.

Was it possible I could be depressed? A wave of guilt washed over me. I was depressed after receiving one of the greatest gifts of my life.

Sure, I had three surgeries: transplant, peritoneal dialysis catheter removal, and a biopsy. I was not able to return to work or school. I was in pain most of the time from the recovery from the surgeries and muscle atrophy. I knew it was going to be difficult, but now it felt as though I had lost control over my mind. That mind, my support group, and my grandma’s home-cooked meals were what got me through all of this. Now, it felt as though I was trapped. I understood this amazing thing had happened to me, yet I was simultaneously reliving the most difficult moments of my past ten years – the moments that I never would wish on anyone.

Since I had discovered it’s so common for transplant recipients to experience PTSD, depression and anxiety, I thought surely my transplant team at the hospital would have a plethora of resources available to help me. This, unfortunately, turned out not to be the case.

In my next appointment with UC Davis, I talked to a social worker. That was the most UC Davis had to offer. When I asked for the opportunity to talk to a therapist, they told me that they didn’t have one for me to see, and none to recommend outside of the hospital. The social worker then informed me they wouldn’t be able to see me regularly. I was on my own to find a therapist who was qualified to help in what felt like a very specific need.

I was astonished that one of the top kidney transplant facilities in the nation didn’t offer any mental health services post-transplant. This started a year-long journey looking for somebody with experience in chronic illness– someone who could help with the mental health struggles I was facing. I set up one appointment with a trauma specialist that my family recommended. During our visit, they told me they believed I had PTSD. At first, it was hard to accept. I did not believe them. I thought that was only for war vets and people who had gone through something truly traumatic. That wasn’t me.

While my search for support continued, my mental health became more of a challenge. About one month after my first incident in Los Angeles, I learned that a player I coached in soccer was diagnosed with a rare auto-immune disease (unrelated to the kidneys). This news sent me into a severe depression that I was not equipped to get out of. When I finally overcame it, I knew–yet again–that I was in need of professional help right away.

I set up a series of initial appointments with different therapists and went through a frustrating time. I had a hard time finding someone who took my insurance and who also had experience working with patients that had chronic health conditions and experienced the same mental turmoil that I had. My diagnosis of PTSD took a long time for me to accept, and even longer for me to begin meaningful treatment.

I felt a lot of shame about the idea of my kidney transplant being labeled as a trauma. This was meant to be the solution to years of battling a difficult illness and now it felt like an extended part of the illness, which left me with a feeling of failure.

What I didn’t know for the first ten years was that the “rock” that I had been was a defense mechanism–a way for me to survive the trauma in my life. I had just simply avoided processing it. This is why, after my second transplant, the pain that I hadn’t processed before was emerging in a way that I had very little control over.

I got my first transplant eight years earlier, when I was 16 years old, but I lost it to a staph infection that put me in the hospital for three weeks and nearly killed me. I’d done a total of four years of dialysis before the two transplants (six months before the first transplant, and three and a half years before the second). I have done chemotherapy, high-dose IV prednisone, and a number of other treatments over the past ten years.

The second kidney transplant was the tip of my PTSD iceberg, which I had ignored for all too long. I received the transplant on July 3, 2017. I stayed in the hospital for seven days after and in a hotel close by for another week after that. For four days in the hospital I had high fevers because of the immune suppressants that I was on. I had eight different IVs because of the iron treatments I was receiving. I had blood drawn every morning at 5 a.m. They removed a nerve block in my side while I was awake. It gave me terrible leg twitches.

When I got to the hotel, I learned that the surgery had damaged a nerve near the incision, causing shooting pain in my groin anytime I tried to lay down past a 45-degree angle. Six weeks later, right when I was walking normally and getting into a regular sleeping routine, I had a surgery to remove my peritoneal dialysis catheter. It left me in bed for three days post-surgery. Another four weeks after that, I had my first kidney biopsy. This was the most minor procedure, but it still left me with some discomfort for about a week. My point is this: transplants are hard, long and invasive. Surgeries in and of themselves are traumatic, regardless of their purpose. Dialysis and treatments for kidney diseases are inherently traumatic for the entire support group, not just the person experiencing it directly.

I’ve been so fortunate to have a comprehensive and almost global support group: my entire extended family, my inner circle, my two donors, friends, work colleagues, NephCure, COTA, nurses and doctors (some of whom I still stay in contact with), and so many people that I have only met once or twice. All of them have been incredible and they are the reason why I am the person I am today (and as mentally fit as I am). I have seen the toll this takes on them. My entire immediate family and I are all in therapy now because of the difficulty of this process–not just because of the second transplant. I think we all wish that we started therapy earlier, and together. I had very little therapy in the eight years leading up to my second transplant.

The therapist I see now once told me, “People avoid or stop going to therapy when they need it the most.” For a long time, I turned a blind eye to therapy.

I did as much as I could to avoid processing the extreme difficulty I was facing in my life. I did this until I was in so much mental pain that I was forced to take action.

Don’t get to that point. Wherever you are in this journey, and quite frankly, if you’ve read this far, simply talking to somebody who has no connection to you and an expertise in mental health is something you need. You cannot and do not need to handle this on your own. Your support group cannot and does not need to handle this on their own.

Even if you do not have PTSD, depression, anxiety, or anything of the sort, therapy can help you process the difficulties we all face from being forced to be kidney warriors. Caring for your mental health can help you live a more balanced life–a life filled with joy.”

-Jeremy Bedig

Externally led patient-focused drug development (EL-PFDD) meetings bring together patients and care partners, US Food and Drug Administration (FDA) representatives, pharmaceutical companies, and doctors who are experts in the particular disease. The goal is to hear from patients who have the disease, in order for the FDA and pharmaceutical companies to understand the patient experience.

This year, NephCure Kidney International and the National Kidney Foundation are coming together to conduct an EL-PFDD meeting, on August 28, 2020, to inform the FDA about the patient’s perspective of living with focal segmental glomerular sclerosis (FSGS). The meeting will be held online. We invite anyone who has FSGS, lives with someone affected by it, or is interested in it to attend this meeting. 

This year’s EL-PFDD meeting on FSGS will be co-chaired by two NephCure Specialists, Drs. Laura Mariani and Suneel Udani. The two of them answer the following questions regarding the importance of patient attendance at the meeting in August.

As a patient with FSGS, why should I consider attending this meeting? 

EL-PFDD co-chair and NephCure Specialist, Dr. Suneel Udani

Because FSGS is rare, most people designing and evaluating the results of clinical trials, that test new medications, have not met anyone with FSGS.  While clinicians taking care of patients with FSGS understand the impact the disease has on your lives, this impact is not something that can always be captured on a blood or urine tests, and therefore regulators who determine which medicine becomes available may not recognize the issues that patients face each day.

This meeting is your chance to explain not only the impact of the disease, but also the limitations of our current therapies. Each patient’s experience is unique, so hearing from as many different people as possible is incredibly helpful.

We encourage you to share not only what you would not only like, but also what you would expect from new treatments in terms of how they are administered, for how long the medication must be taken, the side effects, or anything else you think would be relevant to new treatments.  Each segment of the medical community (clinicians, researchers, industry leaders) benefits from hearing your perspective so that the new treatments available truly meet the needs of the intended population—you.

The EL-PFDD meeting is a unique setting where all these groups—patients, clinicians, scientists, industry, and regulators—are gathered together to listen. Therefore, your attendance and insight are dependent and vital to this meeting’s success.

How does this meeting contribute to putting new medications for FSGS on the pharmacy shelf?

EL-PFDD co-chair and NephCure Specialist, Dr. Laura Mariani

The comments from the meeting can inform the FDA about the urgent need for new, more effective, and less toxic treatment options for FSGS. The FDA tries to bridge communication between patients and the medical community. The FDA aims to develop criteria that not only represents the effectiveness of therapies, but also determines if these therapies truly help people feel better. In gathering patient feedback, this meeting will help companies design better studies to assess the symptoms most relevant to patients and help the FDA interpret the results of those studies with the patient’s needs in mind.

Why does the Food and Drug Administration want to hear from patients?

The FDA recognizes that patients and their family members are the experts on what it is like to live with FSGS and to take the currently approved medications.  This meeting can help the FDA better understand the impact of the disease and its treatments on patients.

As a doctor, why do you believe the EL-PFDD is important?

“As a physician, I have been frustrated with the treatment options for Nephrotic Syndrome since I learned what they were, how effective (or not) they are, and the side effects we ask patients to tolerate. However, for the first time in our history, there are more candidates for treatments and studies to investigate their impact. The potential for multiple new therapies has changed my perspective. Whereas in the past our bar for being excited for a new treatment was simply if it made an impact on abnormal lab tests, now we have to raise the bar to not only look at improving laboratory tests, but also how effective a treatment is at helping someone with the disease live better. We can never have that insight without the patient voice. Rather than hearing about patients’ experience after a new medicine has been approved, the EL-PFDD provides an opportunity for patients’ voices to truly shape the narrative and make sure that the approval process includes the perspective of those living with the disease and what is important to them.” -Dr. Suneel Udani

“I want to be able to offer patients more effective and less toxic therapies for FSGS.  To do that, we need to lower the barriers at every step of the drug development and approval process.  Hearing directly from patients is the best way for our partners in this process to understand the urgency of need in this area and to help all of us improve the lives of patients living with FSGS.” – Dr. Laura Mariani

To register for this year’s EL-PFDD meeting focusing on FSGS on August 28, 2020, please click here. 

Does kidney disease put me at a higher risk?

Patients with protein spilling kidney disease are at higher risk for moderate to severe illness from COVID-19, especially when kidney function is below normal. Many patients are on immunosuppressive medications that work by keeping the immune system less active and in turn, makes it harder to fight infections such as COVID-19. Those with advanced kidney weakness, or on dialysis also have weaker immune systems. You may also have high blood pressure and possibly other comorbidities.

Which treatments are considered immunosuppressive medications?

The following medications that are used to treat protein spilling diseases are immunosuppressive medications:

• ACTHAR
• Belatacept
• Cellcept (Mycophenolate mofetil)
• Cyclosporine
• Cytoxan (Cyclophosphamide)
• Imuran (Azathioprine)
• Prednisone, prednisolone (Steroids)
• Rapamune (Sirolimus)
• Rituxan (Rituximab)
• Tacrolimus (Prograf)

I am not on immunosuppressive medications, but I am spilling protein in my urine. Am I still at risk and/or immune compromised?

If you are actively spilling protein in your urine, your immune system is weakened and you are likely at higher risk of developing severe illness from COVID-19. Because the filtering units of your kidneys are not filtering properly, they are spilling all types of protein including immunoglobulins.  Immunoglobulins, also known as antibodies, are proteins  in the blood that help fight bacteria or viruses and their loss makes your immune system weaker.

I am currently relapsing, should I wait to begin taking immunosuppressants until COVID-19 passes?

You should discuss the best plan of action with your nephrologist because each patient is different. However, your priority (even during the COVID-19 outbreak) should always be to stop your protein spilling and protect your kidneys.  If you generally respond to immunosuppressive therapy, it is likely a good idea to begin treatment. Again, please discuss the risks and benefits with your caregiver.

I am currently in remission, should I consider stopping or lowering my immunosuppressive medication?

During the COVID-19 outbreak, it is not recommended to stop or lower your medications. Stopping immunosuppressants can lead to rejection of a transplanted kidney or a relapse of protein spilling. You should never stop your medications without first speaking with your nephrologist first. There may be rare situations where medications can be reduced or stopped, but only under the care of your nephrologist.

Should I stop taking my ACE inhibitor blood pressure medication?

There have been some pre-clinical and clinical studies linking COVID-19 and the renin-angiotensin system. This has led to speculation as to whether use of ACE inhibitors or Angiotensin Receptor Blockers (ARB) increase the risk of moderate to severe illness in  COVID-19; NephJC and other professional societies have found that the evidence is insufficient, and in some cases conflicting—some data even suggesting that ARBs may be protect the lungs in viral pneumonia. Patients who are taking ACE inhibitors or ARBs should not change their medication unless told to do so by their nephrologist.

To read more about ongoing developments on this topic visit http://www.nephjc.com/news/covidace2

Will there be medication shortages?

There will likely be some drugs on backorder due to COVID-19. It’s difficult to know which medications will be impacted. It’s important not to panic or hoard medications. Call your doctor and/or pharmacy to see if you can get medications filled early or in 3-month supply. It may be best to begin using a mail-in pharmacy during the outbreak. You can monitor information regarding specific drug shortages here.

Should I Shelter in Place?

The key point to remember is that you cannot get the infection without exposure to someone who has the infection.  Therefore, you should make every effort to stay at home and limit your exposure. The degree of quarantine may differ depending on where you live. The best plan is to avoid going out for non-essential reasons and when you do to limit exposure to others and practice strict hand hygiene and clean things that you may have touched before washing your hands (such as your phone and your keys)  Getting fresh air and exercise close to your home, with proper social distance from others is certainly safe and may help cope with the stress arising from this situation.

Should I go to my doctors’ appointments?

It is important to first call your doctor to discuss if you need to physically go to your appointment. Many clinics are offering telemedicine, virtual appointments over the phone or on your computer. If your appointment requires testing or some form of physical treatment, you should discuss if it is essential or if you can reschedule for a later date.

I need labs drawn, where is the best place to go?

Many patients require frequent labs to stay on top of their care. You should contact your doctor to determine if your scheduled labs are required now, or if they can wait a month or two. If you must have labs drawn during the COVID-19 outbreak, consider going to a small outpatient lab rather than a lab in the hospital. Always use good hand hygiene and assure the phlebotomist does as well. Schedule an appointment if possible, go first thing when the lab opens and wait in your car for your turn, to limit your exposure.

Is it safe for immune compromised patients to order carry out meals?

Many restaurants are closed to the public to enforce social distancing but are still open for carry out. There is some risk in ordering food from a restaurant because employees may be infected with COVID-19, but there appears to be other a very small risk of food-related transmission. Should you choose to order carry out, be sure it’s from a valued, trusted business, you can transfer the food from the delivered containers to your own plates and you reheat the food prior to eating.  Other precautions include paying over the phone and asking them to put the meal in your trunk instead of passing the food through your window. Once home, repeat hand hygiene after assuring you have cleaned all surfaces.

How can I combat anxiety and depression during this time?

The fears, worry, and stress that come with being at increased risk for moderate to severe COVID-19 illness are real and can lead to even greater amounts of anxiety and depression. Being separated from friends and loved ones while social distancing can also cause feelings of isolation and loneliness. We want you to know that you are not alone in your struggles.

NephCure is offering a 4 week virtual series about “Cultivating Resilience During Anxious Times: Strategies for Staying Steady while Navigating Covid19” Please join us on Thursday, March 26, April 2, 9, & 16 at 7:00 PM EDT via https://zoom.us/j/890400605

We also offer several ways to connect with others going through similar journeys with protein spilling kidney diseases at NephSpace our online support community and direct connections through our Patient to Patient Connections Program. To talk with someone immediately, contact our Patient Advocate, Kelly Helm at khelm@nephcure.org or 610-540-0186 x38.