Episode 34: Building the Largest Kidney-Focused Genomics Registry with Dr. Michael Anger and Jeffrey Carr
With the ambitious goal of enrolling more than 100,000 participants within five years, the My Reason campaign aims to build the largest kidney-focused genomics registry of its kind. Dr. Michael Anger, Principal Investigator for the My Reason Genomics and Precision Medicine Initiative, and Jeffrey Carr, Head of Genomics and Precision Medicine, join Field Notes to discuss the significant impact My Reason will have on improving outcomes for kidney disease patients.


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Brad Puffer: Welcome everyone to this episode of Field Notes, I’m Brad Puffer on the Medical Office communications team at Fresenius Medical Care North America, and your host for this discussion today. Here we interview experts, researchers, physicians, and caregivers who bring experience, compassion, and insight into the work we do every day. Recently, the Global Medical Office at Fresenius Medical Care launched an important kidney genomics research and discovery initiative called My Reason®. My Reason® is a campaign to encourage enrollment in what we hope will become the largest kidney focused data repository of its kind, linking genomic and clinical data of both chronic kidney disease and end stage kidney disease participants. The hope is that in the future patients and their nephrologists may be able to use genomic information developed from the database to better personalize their treatments. But what is the process for enrolling patients, and what is the science and technology driving this incredible effort? What could be the benefits of this research? Here to explore this exciting new initiative is Jeff Carr, Vice President of Operations and Business Development for genomics and precision medicine. And Dr. Mike Anger, Chief Medical Officer for Frenova and Principal Investigator for the My Reason Genomics and Precision Medicine Initiative. Welcome to Field Notes.

Dr. Michael Anger: Thanks, Brad.

Jeffrey Carr: Thank you for having us.

Brad Puffer: Back in early 2021, we announced that our first patients were actually enrolled in this new genomics registry for kidney disease, and we had the chance at the time to talk to Dr. Frank Maddux about his vision for this registry. Jeff, I want to start with you and hoping you can just set the stage for us and explain the goal of this campaign and a little background on the project.

Jeffrey Carr: Just as you previously discussed with Dr. Maddux, and consistent with what we've released publicly, our goal here really, at a high level, is to engage our patients, and in the broader kidney community to create a large, disease specific registry. And what this is, really, is a repository of rich clinical data paired with genetic information on the participants. We wish to have representation across all stages of chronic kidney disease. And this data will ultimately act as a resource to be a catalyst for acceleration or accelerated innovation of novel therapies, as well as providing insights informing more precise care. And to answer why we're doing this, nephrology, and as we've stated in the past, nephrology has not received investment in cutting edge innovation on the same level that has been seen in other areas of medicine – to name a few, oncology and cardiology. We hope the asset we're building, the capability we're building here will contribute to changing that.

Brad Puffer: And so, Jeff, how will My Reason and this campaign help accelerate these efforts and accomplish our goals?

Jeffrey Carr: In reference to the My Reason campaign, it's really the face of the initiative, that which is directed to the patient, their family, the broader kidney community, and the campaign is asking the individual what is their reason for enrolling, for taking that altruistic step to contribute their health information and access to their bio specimen? And those reasons may include benefit for future generations, including potentially, their family members.

Brad Puffer: Well, Dr. Anger, Jeff did a great job explaining the initiative, but what about the science behind this? If this is successful, what do you see as the promise for connecting the dots between genomic markers and kidney disease? And how will scientists use this data?

Dr. Michael Anger: There have been tremendous advances in research in terms of characterizing various diseases in disciplines that are outside of nephrology based on genetic mutations, but we've been really far behind these other specialties.

For example, in infectious disease, part of the speed with which COVID vaccines were able to be developed was due to SARS CoV2 viral sequencing. In oncology, cancer, a number of cancer treatments are based upon this approach. As recently as in the past ten years, for example, lung cancer was classified as either small cell or non-small cell. It's now described by the presence or absence of over 30 genetic mutations. Mutations in the tumor suppressor genes BRCA 1 and BRCA 2 for example, are linked to much higher risks of not only breast but ovarian and prostate cancers. We now have an exciting opportunity to do the same for renal diseases. This approach will allow a better chance for specific diagnoses which opens the door for newer and more specific treatments. I see medical professionals and other scientists using this information to design a multitude of research studies to discover successful approaches to not only delay progression of renal diseases, but potentially find cures for some. This will truly be a precision medicine approach. That is, one that uses a precise diagnosis and very specific targeted treatments to provide the absolute best care for a patient, whether it be for prevention or treatment.

Brad Puffer: Well, Dr. Anger, that's a really exciting future you've laid out. In order to get there, we're going to need people to participate. That's what this My Reason® campaign, of course, is all about. Jeff, is there a minimum number of enrollees that we need before this repository can really be used for science? I know we have a goal of 100,000 participants. That's a big number.

Jeffrey Carr: What we're doing here is indeed a significant undertaking. It's pretty exciting. I would say there's no magic number of enrollees before the registry and the data asset becomes useful. Yes, when we've achieved scale of a rich data set with necessary participant diversity, we'll have something truly unique to power discovery. But even as we build towards that larger goal, I'm quite certain we'll have the opportunity to collaborate with researchers to drive innovation and accelerate new therapies coming to market. So yes, the goal we've set for ourselves here is bold, but with engagement of patients, their families and the broader, as I referenced before, the broader kidney community, I have every confidence we're going to get there.

Brad Puffer: Well, you referenced just how enormous a task this is. Can you give us a little more detail on the process? From the logistical point of view, how will these samples be collected? How will they be stored? What are we asking of patients and how easy is it to become part of the registry? I'm sure privacy is also something we're taking seriously here.

Jeffrey Carr: We've certainly been busy putting the necessary infrastructure in place, created a self-enrollment solution which can be found at whatsyourreason.com. This is where the participant has ready access to information on the initiative and really can move through an easy process to enroll on this web-based platform. With that participant consent, we collect clinical data as well as the biospecimen. In the case of FKC dialysis patients, our own patients for whom we care, we're able to simply take an aliquot or a small amount of blood that's left over from routine laboratory testing. This being done actually at our own wholly owned reference laboratory, Spectra laboratories. And at those sites, we've also installed ultra-low temp freezers to store those samples. I should note that for those patients, or those participants who are not our patients, we'll have the ability to collect biospecimens whether they be blood or saliva, and we will make it easy. We will then separately work with external next gen sequencing laboratories to generate that genomic sequence data and ultimately pull this combined data, this phenotypic, this clinical data, impaired genetic information into our registry repository. And yeah, I'll comment on the matter of privacy. We have taken and continue to take extensive measures to safeguard our participants' personal health information. So, we've taken that quite seriously and have taken a thorough approach.

Brad Puffer: Dr. Anger, I wanted to ask you a little bit about the work we've done in value based care because we've been working a lot to try to help identify patients with kidney disease earlier, trying to slow the progression of disease. Do you think that using this data and identifying genetic mutations will help even identify patients earlier who might be predisposed to disease or help get ahead of that progression much the way we've seen genes, as you mentioned with breast cancer, identify risk factors?

Dr. Michael Anger: The greatest opportunity this initiative will provide is just that, identifying individuals with various types of chronic kidney disease much earlier in their course when a therapeutic intervention may have the best chance to slow progression. We already have new medications available that benefit illnesses when used earlier versus later in their course. For example, in the inherited autosomal dominant polycystic kidney disease or, in IGA nephropathy. There are currently several companies looking at innovative therapies for these and other monogenic diseases, that is, diseases that have a single gene disorder such as focal segmental glomerular sclerosis, as well as other more complex disorders, including APOL1 associated renal diseases. Having a more specific diagnosis and utilizing these treatments will provide us the potential to slow down the course of many renal diseases and hopefully in many, prevent end stage kidney disease.

Brad Puffer: And are we also seeing changes in the genetic makeup, potentially, of the kidney and the disease in our patients who are often most at risk, those with diabetes or high blood pressure, for example? We know SGLT2 inhibitors, and I recently talked to Dr. Kossman about their power in slowing the progression of disease, especially for people with diabetes, but now, perhaps everybody with kidney disease. Will this project continue to help in those areas and those drivers as well?

Dr. Michael Anger: We certainly hope so. I mean, SGLT2 inhibitors are a great example. They are one of the most tremendous recent treatment advances for a multitude of chronic kidney diseases as you mentioned. The fantastic feature about drugs like that is that they are beneficial for a wide variety of renal diseases, and although we certainly hope we can make other discoveries like that using this initiative, I think a project like ours will create the opportunity to develop very specific therapies for individual diseases, really including very rare ones to allow individualized treatments based upon the earlier genomic diagnosis.

Brad Puffer: It's incredibly exciting and you know, it feels like wow, it's about time. It's about time that kidney disease does this and catches up with some of these other disease states. And it's really great that we're leading this effort. Jeff, it seems that then a patient’s family members, and kind of that family connection, might be equally important to this effort. Is that true? And will family members be able to participate, not just those with identified chronic kidney disease?

Jeffrey Carr: We most definitely want family members of those with kidney disease to participate in the My Reason® program. It's well known that some forms of kidney disease are inherited and that there are genetic signatures which determine predisposition or risk of disease. So, by including family members they will ultimately be enriching the registry, and we hope will further be understanding of disease cause and opportunities for more precise treatment. Again, we've made self-enrollment easy for patients and their family members in the broader kidney community at www.whatsyourreason.com.

Brad Puffer: And I know beyond the website we've got social media that's getting the word out. We actually have flyers that are going into centers starting with Fresenius Kidney Care dialysis centers to educate and inform patients about this. A huge effort, My Reason® is a really, really comprehensive campaign and I'm sure our care teams and patients' personal physicians will be critical to helping explain the value of this project. So, Dr. Anger, as a physician, what reason would you give to a patient to participate, as some may say, well, this won't really help me now, and so I don't see the benefit?

Dr. Michael Anger: Well, that certainly is a likely response, and for many, quite a true observation. I would approach patients by explaining how this may help other members of their family. Jeff touched upon this earlier, their children, grandchildren, as well as their friends. Beyond that, they'll be contributing valuable information that may provide benefit for many generations to come. This is something that they can carry in their heart. Just knowing that in a small way, they help make life better. How they may be able to provide an opportunity for some to not have to go through some of the things they're experiencing, like dialysis. It's painless, easy, and free for them to participate, and the gained information will truly be invaluable, and I so appreciate their considering this wonderful contribution, and I would tell them so.

Brad Puffer: I'm really excited to come back to you in a couple of years to see just how far we've come in building out this registry and see even what new treatments it might eventually help unlock for people with kidney disease. So, thank you so much for joining us today. It's been a really interesting conversation.

Dr. Michael Anger: Been a pleasure to be here, Brad.

Jeffrey Carr: Thank you very much.

Brad Puffer: And to our audience. Thank you for joining us. If you want to learn more about this exciting initiative, you can check out my conversation with Dr. Frank Maddux, our Global Chief Medical Officer. That conversation is episode 17, Building the Largest Genomic Registry, which was recorded in February of 2021. And Dr. Maddux talks passionately about his vision for the registry and about the science of genomics and kidney disease. And if you want to participate, please visit whatsyourreason.com. You can, of course, find more episodes of Field Notes on the Apple Store or Google Play or right here at FMCNA.com. And until next time, I'm Brad Puffer, you've been listening to Field Notes by Fresenius Medical Care. Take care everyone.