NephCure Kidney International Launches Revolutionary Clinical Trial Discovery Tool for Kidney Disease: KidneyHealthGateway.com February 19, 2019 by Kylie Karley (KING OF PRUSSIA, PA- FEB. 19, 2019)- NephCure Kidney International (NephCure), a not-for-profit organization focused on accelerating research for effective treatments for rare forms of Nephrotic Syndrome, announced today the launch of a newly designed patient-centric website, KidneyHealthGateway.com; a resource to help approximately 100,000 Nephrotic Syndrome patients nationwide access expert care and cutting-edge research opportunities for rare and chronic kidney diseases. The website is aimed at assisting patients, through a user-friendly platform, connect to appropriate clinical trial opportunities. After answering several questions regarding their health and diagnosis, patients are shown a list of clinical trials fitting their criteria—ultimately showing each patient their best individualized trial options. “We are thrilled to debut our new website and assist patients by providing access to the optimal care and innovative research they need. There’s more interest in glomerular diseases now than ever before, and in 2019 we’ve seen a marked increase in the number of clinical trials for Focal Segmental Glomerulosclerosis (FSGS), IgA Nephropathy, and other forms of Nephrotic Syndrome. The Gateway initiative also represents a true cross collaborative effort and includes active partners from government agencies, patients, physicians, and research organizations, as well as industry. It’s a crucial time to fill these clinical trials and deliver on our promise to usher in better treatments for our patients,” Joshua Tarnoff, NephCure’s CEO said. Because KidneyHealthGateway.com is designed to improve many aspects of a patient’s quality of life, the website will also include a list of ‘Nephrotic Syndrome Specialists’ in order to connect patients to glomerular kidney disease experts earlier in their diagnosis. Delay in finding expert care can result in a lack of access to contemporary treatment approaches and a delay in gaining access to potentially relevant clinical trials. The goal of the Nephrotic Syndrome Specialists program is to improve patients’ quality of life and reduce the potential for irreversible kidney damage by providing earlier access to clinicians who are specialists in and routinely treat Nephrotic Syndrome. The ‘Nephrotic Syndrome Specialists’ program and KidneyHealthGateway.com are two parts of a larger, all-encompassing initiative NephCure has created to grow the glomerular kidney disease community and ultimately fill clinical trials. This ‘Gateway’ initiative also includes six professional working groups addressing barriers to patient recruitment, and the expansion of this patient community through global engagement and the inclusion of all primary glomerular kidney diseases. In service to this initiative, NephCure has formally partnered with the IgA Nephropathy Foundation of America with plans to complete a full organization merger in the future. Aliza Thompson, MD, MS, Deputy Director of the Division of Cardiovascular and Renal Products in the Center for Drug Evaluation and Research of the FDA, announced, “We are hopeful that this initiative will improve outcomes for our patient community and lead us closer to providing safe and effective treatments for primary glomerular kidney diseases.” Support for KidneyHealthGateway.com and the overall initiative to improve access to care and ensure trial recruitment is provided by Retrophin, Inc.; Pfizer Inc.; Mallinckrodt Pharmaceuticals; Reata Pharmaceuticals; Variant Pharmaceuticals, Inc.; Goldfinch Bio; Achillion Pharmaceuticals; and ChemoCentryx. 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. Specifically, NephCure is focused on glomerular diseases such as: FSGS, IgA Nephropathy, Minimal Change Disease, Membranous Nephropathy, C3 Glomerulopathy, and Membranoproliferative Glomerulonephritis. NephCure is headquartered in King of Prussia, Pennsylvania. For more information about the organization, visit NephCure.org or call 1-866-637-4287.
Dr. Ahmed Awad: Why Participating in Trials Helps Patients Most of All February 4, 2019 by Kylie Karley NephCure Kidney International recently sat down with Dr. Ahmed Awad, a nephrologist in Kansas City, Missouri, to learn more about his company, Clinical Research Consultants, and find out why he believes clinical trial participation is so important. He also delves deeper into the DUPLEX study (specifically for FSGS patients), breaking down what participants can expect, how to get involved, and what the near future may hold for those diagnosed with Nephrotic Syndrome. Dr. Ahmed Awad, CEO and Principal Investigator at Clinical Research Consultants NephCure Kidney International: You founded a company, Clinical Research Consultants, specifically to help support clinical research. Why is that so important to you? Dr. Awad: I started back in 2008-2009 when there were more normal drugs coming on the market to specifically treat kidney disease. Up until about 2010, the majority of our treatment had not been specific to a particular disease. But I thought, “In the next 5-7 years, we will have more medications coming on the market that can treat a specific glomerular disease or a specific kidney disease, for a specific patient, rather than just giving them a general treatment with prednisone.” We did not have enough armaments in our hands to treat kidney disease, but I knew the future was coming, and that’s why I wanted to be more involved in clinical research. NephCure: Why is it important for patients to participate in clinical research, or to take control of their disease early in their disease journey? Dr. Awad: I do believe patients who participate in clinical trials get better care than when they only see their primary care physician or their regular nephrologist. In the real world, out there in the clinic, patients would typically be seen once every 3-4 months, and there’s not much education—labs can vary from one month to another. Whereas when a patient participates in clinical research, they would be seen by the specialist and study coordinator more frequently: between once a week to once a month. And the patient gets more in-tune with the disease process because they’re getting this reinforcement of seeing the study coordinator and seeing the study physician very frequently. They seem to be more in tune with their disease, and can learn more about living with their disease. Which means, in my experience, they seem to really do much better in the clinical trial than when they just see their specialist once every 3-4 months. NephCure: What’s the biggest obstacle patients face when enrolling in a clinical trial? Dr. Awad: Awareness. I think patients do not know there are clinical trials for these different types of kidney disease, and also, the physician may not be offering them. The physician may not even know that there are so many clinical trials out there to help with chronic kidney disease. NephCure: One of the studies you’re involved in enrolling patients in is the DUPLEX study for FSGS patients. What’s unique about this trial? Dr. Awad: It has a unique mechanism of action. It is a dual treatment—it not only works as an angiotensin receptor blockade, but also is an antecedent. It inhibits the antecedent from getting vasoconstricted, meaning clamping the blood vessels. So it has a dual mechanism of action in reducing protein in the urine, and we know, historically, that reduction of protein in the urine delays the progression to end stage renal disease. That’s the beauty about the DUPLEX trial with Sparsentan. The dual mechanism of action is not only an angiotensin receptor blockade, but it also has an antecedent activity. NephCure: So this is a drug that could potentially help all FSGS patients, whether they’re steroid-resistant, steroid-dependent, or not responsive to other treatments? Dr. Awad: Definitely, because it has the potential. We saw in the Phase II clinical trial, called the DUET study, that this drug, regardless of their FSGS’s resistance to steroids or not, showed a reduction of proteinuria. That’s why there’s now a Phase III clinical trial for this drug. NephCure: What’s involved for patients that want to participate in this study? Dr. Awad: It is an oral tablet. The trial is for about 2 years. The patient will visit us once every two weeks for the first two months, then once every four weeks for the next few months, and then after that, once every 3 months. Every time they come in, we check their bloodwork, and we check the amount of protein in their urine. NephCure: What would you say to someone who’s on the fence about participating in a trial, or in this trial specifically? Dr. Awad: Our motto here at Clinical Research Consultants is “Helping you, helping others.” I always tell my patients, if it wasn’t for people like you who participate in these kinds of clinical trials, we wouldn’t have the medication we are giving you right now, or one that has been approved by the FDA. Any patient who participates in a clinical trial is contributing to society by helping others, as well as themselves. NephCure: Do you have any final thoughts you’d like to add? Dr. Awad: I think we’re on the verge of a true treatment for glomerular diseases, more specifically the different types of kidney disease. It is not going to be a general treatment for all of them, it’s going to be a specific treatment for a specific disease. We know now the pathophysiology, the specific pathway in the development of this, and we even know what gene that can turn on or turn off the process of kidney disease. And there are so many medications, so many clinical trials undergoing to treat these different types of kidney disease. We will have treatments in the next 3-5 for all types of kidney disease. We encourage you to learn more about the DUPLEX Trial and other studies that might be right for you at kidneyhealthgateway.com.
Spotlight On: Meredith Wilson, National Events Manager at NephCure February 3, 2019 by Kylie Karley Meet Meredith Wilson, the woman behind the elaborate NephCure Kidney International events taking place across the entire country. Her meticulous planning and detail-oriented eye has made for many successful galas, walks, conferences, and more. This Disney-obsessed National Events Manager is celebrating her 5th anniversary with NephCure this year. We sit down with Meredith to learn more about her crucial role at NephCure and find out what she’s planning in the near future. NephCure: Can you believe you’ve been at NephCure Kidney International for 5 years? Meredith Wilson: My first day at NephCure was May 27, 2014, I started as an intern and never thought I’d still be working here almost 5 years later. NC: How did you originally get involved with NephCure? MW: I was unsure what direction I wanted to take after graduating college and thought it’d be interesting to try out something completely new. A friend of mine was working for NephCure at the time and mentioned to me they were looking for a summer intern. The experience was great, and I was curious to see how a nonprofit is run. NC: What different roles have you held during your time at the organization? MW: I’ve had many different roles during my time here at NephCure. Like I mentioned earlier, I started as a Special Events Intern assisting with our golf outings and galas. I then became a Regional Walks Manager on both the East and West coasts. After that, I stepped into the Regional Events Manager role, planning all of our East Coast events. And finally, I was promoted to the National Events Manager—which is my current title. That role has shifted a lot over the past few years as we continue to add more and more new NephCure events across the country. I’ve taken on roles from other departments when needed, like Operations and Conference Management, in addition to coordinating all of the administrative and logistical tasks for every fundraising event. NC: Which one has been your favorite? MW: My favorite role has been planning the annual NephCure Leadership Summit where all our top volunteer leaders come together to discuss their journeys, share their tips, and learn about NephCure’s new initiatives. It’s a great event, and I love planning it because it involves input from every department—the organization works as a whole to put together a fun and educational weekend for our volunteers. NC: What do you like most about working for NephCure? MW: There’s always something new to plan. I love starting a new project and then watching it come to life from beginning to end. It’s very rewarding. We have a great staff and it’s been a pleasure working alongside my colleagues, especially the ones who have been here as long as I have and have watched the organization grow and adapt to changes in the industry as well as the work space. NC: What is it like to plan such big events like a Countdown to a Cure gala? How much work really goes into it all? MW: Endless amounts of work! Every year I always say I wish I had more time! Countdown to a Cure, in particular, is a massive event that requires so many moving parts behind the scenes to ensure a successful experience for each of the attendees. NC: What things are you most excited for in NephCure’s future? MW: I think I’m most excited about the magnitude of new events we have coming up this year. In total, NephCure will have 4 brand new events in 2019! This is most new events we’ve ever had at this level. And none of it would be possible without the dedicated, hard working volunteers that have a passion for helping NephCure. They always bring new ideas to the table and it’s so fascinating to see their hard work come to life! NC: When you’re not at work, what are you most likely doing? MW: I might be at Disney World! I’ve been four times in the past year. I love all things Disney, especially Tinkerbell! Outside of that, I’ve recently joined the Young Professional’s Board for Uplift Center for Grieving Children. We are volunteers who promote the Center’s mission, run fundraising events, and assist the center in any way to ease their workload. It’s a wonderful opportunity to give back through another organization and network with local professionals.