VO OPEN: Nephrology has been underrepresented in clinical research, even as rapid progress in gene sequencing and analysis has led to advances in precision medicine and individualized care in oncology, cardiology and other medical areas. Frenova Renal Research is building a Genomics Registry to analyze genetic sequencing data from chronic kidney disease patients worldwide. Analyzing these genetic sequences will help evolve our understanding of these disorders. Joining me is Kurt Mussina, President of Frenova Renal Research. Frenova is building a new Genomics Registry that will help redefine kidney care. Kurt, I'm really glad to have you here today. This is a bold project. What's the goal and why is this Registry so important?
Mussina: The goal for the Registry is really to catalyze a better understanding of the molecular underpinnings of kidney disease; and we intend to do that by recruiting and consenting many tens of thousands, and indeed upwards of a hundred or more thousand, I would say, participants, not necessarily just patients with kidney disease. So, we need to include their family members as well, and we hope to build a Registry that is both geographically and ethnically diverse.
Maddux: Tell us a little more about what's involved in creating the Registry. What do you have to do?
Mussina: We're starting today, sort of in a pilot phase, where we're approaching Fresenius Kidney Care patients and consenting them into the Registry. Before all of that, there was a whole lot of work that had to happen. We had to develop a protocol for the Registry. We had to find a Principal Investigator, which we found in Dr. Ali Gharavi at Columbia University. We had to get the protocol approved by the IRB, we had to develop recruiting and consenting materials, including an informed consent form, and have that all approved by the IRB. And then we've been working very closely with our colleagues in Fresenius Kidney Care, as well as our physician partners in Frenova's Managed Site Network, so that we can enter into these clinics and approach our patients with the idea of consenting into the Registry.
Maddux: Tell us a little bit about who can participate in the Registry. Who are sort of the target audience?
Mussina: Today, it's generally limited sort of Fresenius Kidney Care dialysis patients. We hope, though, to expand that into patients who are non-dialysis, chronic kidney disease. So, patients under the care of our physician partners. In addition to their family members, and others, I don't think we'll wind up with a allcomers from all over the world. This is very much a renally-focused endeavor, so I would say the end goal is people with chronic kidney disease in some form or another, not necessarily just end-stage renal disease.
Maddux: Any response so far from patients or any sense of what you think their interest or attractiveness to this project are?
Mussina: When we started with some patient interviews and focus groups before we ever got started with anything, just to make sure that this was something that would be appealing to them, and the response then in those focus groups was very positive and we've seen that carry over today into the work that we're doing now. Of the patients that we've approached, I would say the vast majority, upwards of 80 percent or so, have indeed agreed to consent and have given their okay to participate. So, it's very encouraging, and it's consistent with some of the other research that I've seen in past years about a willingness among, particularly patients with kidney disease to participate in clinical research, if given the opportunity.
Maddux: Kurt, tell me a little bit about the My Reason campaign. And this campaign for looking to create awareness for patients.
Mussina: We have this website called WhatsYourReason.com. and it’s a website that we’ve built where folks can go to learn more about what we are doing and how we are doing it, Not just patients, but friends, family members, and physicians. And today it’s largely just informational. We will be expanding that and evolving it to include other things like the ability to consent electronically into the registry and then we will follow up with ways to operationalize someone’s involvement in it. But we built largely on, like I was saying, the focus group results that we got early when we were when we put this all together. Where there is very much a sense of altruism and so you see that on that website where folks are talking not so much about a benefit to themselves today, but what may come to future generations. So. Again, it’s WhatsYourReason.com
Maddux: Let's talk about research in kidney disease in general. Give us sort of your take on the state of research in kidney disease today, and where you think it's headed.
Mussina: it's kind of interesting if you compare investment and R&D dollars in nephrology to other disease areas in particular like oncology. I've seen in other presentations back to 1960 or so, for the last 40 or 50 years or so, you look at the number of randomized clinical trials in nephrology compared to the number of randomized clinical trials in other disease areas, especially oncology, and there's a huge disparity there. Nephrology is way down at the bottom, compared to every other disease area. And I think that's probably true as we sit here today. I think there's reasons for that, but I do think that it is changing, and I think the work that we're doing here with the Registry, if it all comes together, the potential there is to really catalyze, like I said, at the start-- really catalyze more research into nephrology and the underlying molecular dynamics that lead to kidney disease. So, I'm encouraged by the work that we're doing. I would say today, we still lag in nephrology. Not just in R&D dollars, but randomized clinical trials, you know, just about on every measure, we lag other major disease areas by organ or by any other measure.
Maddux: Are there other barriers that you see to the building of the Registry or the development of researchism or standard offering to patients?
Mussina: Yeah, it's kind of interesting, too. Thanks for that question. Some of the research we've seen would suggest that in oncology, in particular, research is offered as a standard in that disease area in cancer. I've seen figures where they've compared that to renal disease in patients with kidney disease, and how offered they're offered clinical research opportunities and it's half or less than other disease areas. And I think those barriers are really-- you know, how do we overcome that? And I think that's really a matter of awareness and education and you know, making people aware that there are research opportunities out there, and again, if we reach the full potential of Registry, and we catalyze more opportunity there, then that's an even better story to tell. But there are barriers. One of the biggest in clinical research in kidney disease is just the fact that there are a lot of comorbidities that cloud the results. It's hard to get clear-- hard to identify clear endpoints in these clinical trials in the kidney disease. But I think as we bring about more precision in nephrology, we'll see more activity and a more clear path to a good outcome.
Maddux: Your teams that manage our clinical research sites and the interactions with patients, probably get a sense of how receptive patients are to an idea of clinical research or an opportunity to look at how to improve care. What do you hear from them in the receptiveness of patients?
Mussina: Again, it's an interesting question, and things that we've looked at before. Well, we know that our patients want to hear about clinical research. The person that they want to hear it from tends to be their nephrologist. They tend to discuss the opportunity with their friends and family just as a bit of validation, I think. We know that it's difficult to recruit incident patients into the studies, just because things are just so new to them at that moment. But once they're settled in-- I'm talking about here about the dialysis patients, you know, once they're settled into a routine, they want to hear about those studies. And if the nephrologist brings that opportunity to them, it tends to resonate, and they tend to pay attention to that. I think they tend to take the informed consent home, talk it over with their friends and family and then come back and have a broader discussion with our Coordinators.
Maddux: We have pretty large goals in developing a Registry that's big enough to interrogate some of the more complicated features of the genetic code. How do you look at the goals and the timeline that it's going to take to actually build this clinical asset that the field will be able to use?
Mussina: We obviously want to do it right. We are proceeding with the patient in mind, which I said as we started, it was with focus groups and we're building this Registry of, you know, very clearly with the patient in mind. Abiding by all regulatory compliance and privacy considerations and all. So, you know, I would say it takes a while. I think we've got some lofty targets for this year, And to get there will not be through sort of a high touch framework like we are today. We need to figure out what are the sort of digital and electronic means and more mass communication using social media and other tools that we have So, it'll take us a few years to get to really big numbers. But I think along the way, we'll have enough patients consented, and enough sequences available to begin to catalyze the kind of work that we're talking about.
Maddux: The pandemic has changed the way we approach clinical research in a lot of ways, and I think actually enhanced some of the acceptability of these electronic methods. Have you seen that? Is that going to impact this particular project?
Mussina: I think in this case, you know, on the Registry, we will be using more telehealth type tools to be able to reach out to patients. think that's consistent with what we've seen in our dialysis business with the pandemic, and I think it's consistent with what we've seen just in clinical research in general, where these technologies, I think, existed pre-pandemic but were not readily taken up or adopted until we were impas-- we, being a clinical research community-- until we were forced to by the pandemic. So, I'm encouraged by all that, and I think we'll see improved efficiencies.
Maddux: it is a bold project, and I think one that is of high interest to many of us in the field, and I want to congratulate you on getting it started and off the ground and just ask you any final comments before we finish today?
Mussina: I think my last comment would be consistent with what I said before. Really awareness to the extent that we can make some noise and collectively and get people engaged and involved. And I don't mean just patients, but I mean nephrologists, family members, the general public, and public academia, you know, not just industry. I think that'll go a long way towards achieving the goals of the Registry.
Maddux: Have you seen interest externally to our company, and as they've heard about this project?
Mussina: Oh, sure, yeah, yeah. It's sometimes a little bit hard to keep up with the inquiries and interest from outside parties, including academia, industry, patients, physicians, yeah, of the entire gamut of stakeholders in this. So, it's great to see. It's very encouraging.
Maddux: Well, listen, Kurt, thank you very much. Good luck with-- as the project evolves throughout this year and the coming years. And I appreciate you joining me on the Dialoges segment today.
Mussina: Same here, Dr. Maddux. Thanks so much