Bri (00:00):
Dr. Mehta and Shana. I am so glad that we’re gonna be able to sit down and talk today because I truly can’t wait to learn more about the research elements that go into chronic kidney disease and how Dallas nephrology associates are involved, because I’ve had a chance to meet a lot of the team and talk about these other aspects of the work. And I think what y’all do is such an important aspect of when we look into the future as well. So first Shana, I would love to ask you what, what is a clinical trial? We break it down.
Dr. Mehta (00:30):
Clinical trials that we do at Dallas nephrology are either device studies or we’ll do new drug therapy studies. So there’s that we can run the gamut on, on any kind of clinical trial with medications, infusions runs the gamut.
Bri (00:49):
How long do they go? Like, is it something that happens over the span of years?
Dr. Mehta (00:55):
We have some studies that will last about 12 weeks and then we have other studies that’ll be about six years, seven years.
Bri (01:00):
Interesting. And so that runs for looking at non progressive chronic kidney disease, as well as progressive. Does it like, do you separate it?
Dr. Mehta (01:10):
All of it. Yes. And it breaks down to different indications depending on the specific diagnosis of the patients and their type of kidney disease that they have.
Bri (01:20):
And so at any one time, how many do y’all have going on?
Dr. Mehta (01:23):
We currently have 21 ongoing studies and we have about 15 studies that we’re working on starting at.
Bri (01:30):
And so what role for, for you does an investigator and other study team members play during a clinical trial?
Shana (01:39):
So the principal investigator is ultimately responsible for the car of the trial. So it starts from patient safety, patient wellbeing to whether this patient is eligible for this study. Do they meet all the inclusion criteria? Do they have any exclusion criteria as well as during the trial, if they have an UN unexpected unanticipated event, then the principal investigator is responsible for controlling the variables as they say?
Bri (02:04):
Controlling the variables as they say that’s correct.
Bri (02:08):
I took science, you know? And so how often are in communication? Like what’s the relationship between your two roles, you know, when you’re doing these clinical trials.
Dr. Mehta (02:18):
Daily, too much.
Bri (02:19):
Daily?
Dr. Mehta (02:21):
Several times a day.
Shana (02:23):
We are texting back and forth regarding various studies and various patients and things happening back and forth.
Bri (02:31):
And so like in terms of documentation, is that something like that everyone is responsible for? Or is that your role specifically?
Shana (02:39):
Documentation is something that I hate about clinical trials. That’s probably the only thing I hate about clinical trials and every time I visit Shana, there’ll be a nice file for, for me to sign and look over. I mean, these could be labs or these could be adverse events that have happened in this study at different locations. And so there is a lot of paperwork involved.
Bri (03:01):
I’m sure there’s approval levels and things like that, which we’ll probably get into a little bit more just in terms of what the results, you know, how those are certified or whatever that looks like at the end. So are, you know, are there phases or stages of clinical trials?
Dr. Mehta (03:19):
We do phase one through four clinical trials, one being basically the first time in humans, Four being an aftermarket, the drug is already on the market. It’s already been proven safe, but they’re testing it for another indication where they’ve seen that it helps out with this indication as well. I, what it’s already marketed for. So we’ll, we’ll do those studies as well.
Bri (03:42):
And so this may seem like a silly question, but is it around chronic kidney disease in and of itself or the drugs specifically for it like the clinical trials that you do?
Shana (03:53):
So different trials have different indications? So there are some studies and drugs that are it just to chronic kidney disease, but a lot of times now we can subdivide this as the cause of the chronic kidney disease and have drugs directed towards that. For example, diabetic kidney disease or high blood pressure related kidney disease, or there are these rare kidney diseases like Fabry and outputs that are genetic and they have very limited treatment options for right now. So that’s one of the greatest advantages of doing a clinical trial is, is from a patient standpoint, you are able to get treatment for something which may not be treatable in the current scenario.
Bri (04:34):
So, and so why are these clinical trials or research studies important and necessary?
Dr. Mehta (04:40):
So we can that’s no, every, every drug that is out there, every medication has been run through a clinical research study.
Bri (04:51):
Absolutely well. And so why should a patient consider volunteering actually for, for one of these clinical trials that y’all are doing?
Shana (04:58):
So if you take a step back and look at most trials, they’re designed to standard of care versus new drug. So if, as a patient, if you’re enrolled in the trial, you’re at least going to get the standard of care treatment, whether that is just monitoring of the disease or actual treatment with medications, then if you’re actually assigned to the treatment arm, in addition to the standard of care, you get something extra. Mm. So there is no harm. I mean, I shouldn’t say no harm, but there is minimal risk. And the tar trials are designed in such a way to minimize that risk and see if we can intervene early. If there’s a risk that’s identified, That’s the benefit that you get new something new.
Bri (05:41):
And so say somebody does volunteer. What is, is that relationship or process start to look like when somebody decides they are gonna take part in a clinical trial?
Shana (05:51):
So the first step is a chart review and a discussion from the principal investigator with the patient’s treating physician to see whether they would be a good, good patient for the study. And once that’s done, the patient would actually come in for an informed consent where we would go where I think it’s like a 25 page document.
Dr. Mehta (06:12):
21 to 25 pages.
Shana (06:14):
Give adequate time to read through the document. And then the investigator meets with the patient and goes over all the possible risks in the study. As long as a patient is comfortable with that, then we move forward with, with whether they, they would qualify or not.
Bri (06:29):
And so does that normally happen within, you know, a couple weeks time? Or is that something like, you know, I can imagine if you don’t have people volunteering.
Dr. Mehta (06:38):
It’s different for every study and every patient we give the patient as much time as they need to feel comfortable. So it may take three months for a patient to come in and decide that this is something that they wanna do. Or we have some patients that call us and say, Hey, I wanna try something new. And they, we have to slow them to make sure that they are completely aware of what they’re getting into.
Bri (07:01):
Yes, rehash again, just so we’re clear, these are the risks. And so do you have multiple patients involved in in a single trial and then you’ve got multiple trials going on at the same time. And so is your role in all of that? Being able to I don’t know, manage project, manage the, the trials in and of itself.
Dr. Mehta (07:25):
I’m the research manager. We have a team of five other coordinators and we have a recruiter and those coordinators, they manage everything in these studies. They will from identifying patients becoming very close and they have personal relationships with the patients because they’re all in it together. They will also be texting Dr. Metta frequently. So as a principal investigator, he’s getting hit by at least four or five of us each day.
Shana (08:02):
Keep me on track. Right. You know, most of the times there’s so many moving parts that the coordinator’s able to pick up sooner and they’ll be like, Hey, do you wanna follow up this patient sooner or later? You know? So it’s, it’s, the communication is very, very important.
Bri (08:18):
So how is Dallas nephrology is so associates involved in clinical research today?
Shana (08:23):
So Dallas nephrology associates has built the entity renal disease research Institute, and the sole purpose is clinical research for that entity. So I’m gonna refer to them as our DRI R DRI has a bunch of trials in kidney disease. If you take a step back and think about kidney diseases and research, we are in an infancy where like oncology was 40 years back, but you used the same chemotherapy, no matter what cancer you have. I feel as if chronic kidney disease is in that, that era where you use the same two or three drugs, no matter what kind of kidney disease you have. And it’s a mixed bag. The problem has been, we’ve had very limited research. That’s dedicated towards kidney and the causes of kidney disease. That’s what we’re trying to change.
Bri (09:12):
Absolutely. I can imagine, especially because there’s so any different peripheral, like, you know, things that can affect kidney disease out, you know, if we’re talking about diabetes, something with your heart, all of those elements then affect what medications. And if there’s only two, you only have two ways to, to potentially address the, the issue. So I’d love to talk more about RD. I, and so what types of clinical studies are currently available for patients with kidney disease?
Dr. Mehta (09:40):
We have, you mean for the different indications? . We are currently enrolling in studies for polycystic kidney disease.
Shana (09:58):
We have some kidney diseases where your so manifestation is just protein loss in the urine. So things like IG nephropathy focal, segmental, sclerosis these are in the old days all punched up together and had only the same drug, but we have separate studies going on with all of these.
Bri (10:20):
Well, especially if somebody’s listening right now, being able to hear their specific type of that, right. Actually feels like they’re getting more of a custom care plan. And I can, you know, from everyone I’ve talked with so far, that seems like such an important aspect is being able to be tailored to a patient in their history.
Dr. Mehta (10:36):
And we also are also to doing studies for post transplant studies as well, trying to prevent rejection infection.
Shana (10:48):
In transplant patients.
Bri (10:50):
That’s incredibly important. So how do I decide if I’m a patient, if I want to participate in a clinical trial?
Shana (10:58):
So I would talk to my treating physician first. If your treating physician is aware of some places that are doing clinical trials in your particular indication, that would be the best way. There are other websites that you can go to. Clinical trials.gov is a national website that lists all the clinical trials that are currently enrolling. And then N I D D K the national Institute of diabetes, digestive and kidney diseases. They have their own websites, that list clinical trials that are currently enrolling and whether you would qualify for
Bri (11:33):
So you can be a DNA patient and then obviously work with DNA nephrologists, but then also work through specifically, on those clinical trials. And then if they want to seek elsewhere, they can,
Shana (11:45):
That’s very true. And we’ve had patients reach out to us that are not even DNA patients.
Dr. Mehta (11:50):
You do not have to be a DNA patient to do study with us.
Bri (11:54):
I’m so glad you mentioned that that’s definitely an important piece. Yes.
Shana (11:57):
We’ve had patients that, that have never seen Dallas nephrology or any nephrologist in the past and, and are reaching out because they’ve heard about the study and that we are doing the study. And so they would interesting.
Bri (12:12):
How does that come about?
Shana (12:14):
That primary care doctor has been managing their illness. And so, but they’ve, they’re, we’re branching out and looking for other opportunities.
Bri (12:23):
And so where could I find out more information about the clinic clinical research trials?
Dr. Mehta (12:28):
You could go to our website.
Dr. Mehta (12:36):
Google R D I, or you could do renal disease research Institute.
Bri (12:41):
And through there be able, do they apply through the website for some of the trials? Yes.
Dr. Mehta (12:46):
Yes,
Bri (12:46):
So they don’t have to be located in Dallas either, correct?
Shana (12:49):
Correct.
Bri (12:50):
This is open to some of those rural locations and rural patients.
Shana (12:55):
We have, we’ve had patients drive in three or four hours just to be able to be on the study here.
Bri (13:02):
Yes. I was gonna say, does it require regular appointments, like with, you know, is it a nephrologist incorporating a clinical trial information and questions in their appointment? Or is this something that’s being, you know, anything to the clinical trial?
Dr. Mehta (13:17):
We have specific protocols that we’ll follow, and those protocols will determine the scheduling of how frequently we see the patient or speak to the patient. So we will follow that protocol as well as the patient continues to see their treating nephrologist. There will be communication between the principal investigator and the treating nephrologist to make sure that the patient’s getting the best care.
Bri (13:41):
Got it.
Shana (13:42):
So these two appointments were run in parallel, so to speak. So the clinical trials frequently we’ll see the patients more often because we are looking for adverse effects and making sure the patient’s safety is not compromised. And the treating nephrologist or primary care physician, whoever has referred them will not be checking in as often. And they will be getting all the information from us as well.
Bri (14:05):
I was gonna say, so how important, I mean, it sounds like the relationship between you as an investigator and the nephrologist is an incredibly tight relationship.
Shana (14:12):
That it happens a lot. Where do I get a call saying Hey, I’m seeing the patient or patient in common how do, how are they doing, what is the last trial I’m seeing that patient this afternoon? What does the last labs look like? So, , that, it’s very important that the patient’s physicians involved in the decision making.
Bri (14:33):
I was gonna say that was one of the questions that, you know, how do I contact someone about if I am considering applying to be a part of a clinical trial you know, how could I get in contact with someone to be able to acquire any information about my participation? So would that be through the website as well? . Are there any final words around the importance of clinical research studies today? You know, how they’re, how they’re happening today and what that means for the future. I’d love for you to share your thoughts?
Dr. Mehta (15:02):
I think that clinical research is the most important thing we have for patient care and treatment. If we can’t find the new medication and the devices to help these patients with their quality of life, what do we do? And as he said, there’s very little treatments for patients that have these specific kidney disease we need to do better.
Bri (15:27):
Do you see the out of clinical trials continuing to increase? You know, I’m sure there’s only a certain, a load amount that you can handle at any one time given patients, but is that something that, because it’s such an infancy standpoint of research that they’re going to continue doing more and more?
Shana (15:47):
I have no doubt. That’s correct. I think there will be a lot more research going forward. And if you just look at R DRI and Dallas nephrology we have the ability to do a lot more research than we are currently doing. Oh . Just because of the number of patients that we follow we should be able to do and enroll a lot more patients in a clinical research.
Bri (16:07):
So what do you feel like is the biggest break through that’s happened over the last, let’s say five years?
Shana (16:18):
Well, there are plenty. I’m trying to think how to prioritize in the kidney world, there is a new class of medication called SGLT two inhibitors. Those are actually diabetes medicines, but they’ve been shown to improve kidney disease as well. Then there’s anemia and kidney disease. We now have pills for anemia and kidney disease, which we used to have shots and patients had to come to the clinic every week, every two weeks to get those shots. And now we have oral medications that will do pretty much the same. And I think those two probably are the biggest developments in the last two years.
Bri (16:50):
Has R D R I been involved in any clinical studies that have received FDA approval?
Shana (16:56):
Yes. So the R DRI has been involved in a DNA study. So dialysis patients frequently suffer from chronic itch. And there have been a lot of investigation into trying to figure out why and what to do about it. One of the studies that we were involved, when a principal investigator for it actually is a medication that helps with this chronic edge. And it got FDA approval just recently.
Bri (17:24):
Fantastic. I can, I mean, that’s something you lose sleepover that, I mean, truly that that’s gotta be a game changer for so many patients,
Shana (17:31):
Quality of life is much better on those patients.
Bri (17:35):
So from your perspective, working with DNA, being a part of DNA overall and helping slow the progression of chronic kidney disease, what’s been the biggest impact for you, like in your career?
Dr. Mehta (17:48):
I love working for DNA. I have enjoyed working with our different investigators and our nephrologist. I am sometimes just wild by how smart and dedicated and how much they care and how open they are for us. You know, that don’t know it much about these diseases to actually take the time, to help explain to us as well. So when we’re speaking with patients and participants that we can actually give better and informed information, I think that it’s a great place to work.
Bri (18:25):
The research is like you said, critically important, because if we wanna look at what things look like 20 years from now, ideally you have far more options, you know, to be able to extend as, you know, as a nephrologist or just as part of the support care team to be able to offer to, to patients that are that much more personalized.
Shana (18:45):
I think we have to reach precision medicine, what we have right now, broad strokes. We need to be able to customize the patient’s care to the degree that that will impact them rather than saying the same medicine’s gonna work for, you know, you have high blood pressure here, take a pill and go away. Now we need to be able to have precise control of how patients do.
Bri (19:08):
I’m sure patients are incredibly grateful for the work that you do, even if you feel like you’re absolutely crazy and running around all the time, hopefully your work continues and continues to grow even more. Thanks so much for taking the time today, though, to be able to share a little bit more about what that looks like.
Shana (19:24):
Thank you.