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.
*I also tried to leave this post on the story of the patient who has had success with rituximab**
I am proud to say that my daughter was the first (and only child at the time) admitted to an Adult-only NIH (US) study in 2009 testing the effects of Rituximab on Nephrotic syndrome/FSGS. She was initially steroid responsive, then dependent (ended up in a wheelchair due to lumbar compression from steroids) and finally steroid unresponsive. Rituximab was the last choice to save her native kidneys. She underwent the first dose and did remit. This lasted for about 2 months until her B cells repopulated to about 300. She had a total of 13 infusions over 15 months. She always remitted and then would relapse about a month later. Alas, it was deemed that there was nothing more they could do for her, her native kidneys were most likely too scarred from the proteinuria she had been suffering from since 2004 (diagnosed at age 2). She ended up having a bilateral nephrectomy at age 9 and living donor transplant at age 10. She is 6 years post and doing amazing! We are grateful for no recurrence of FSGS. I cannot stress the importance of clinical trials. She would not be here today if it wasn’t for the brave trialists before her! I am proud to say that my daughter was somewhat of a pioneer in understanding the efficacy of a drug which now seems to help so many others. All the best!
Being treated for FSGS by Kaiser for 5 years. Currently tstabilized taking 5mgd prednisone & 1000mgd CellCept. Smaller dosages of either drug triggers proteinurla. Would appreciate updates and would consider opportunity to participate in your trials.
Hello Dr Ahmed,
My Daughter, Mary is 32 and in January of this year, was diagnosed with MCD disease. I have contacted NephCure and the people are nice and don’t have answers for me. I know that I would need referrals to take to find other opinions.
Wondering, do you know if there are new drugs out there for MCD disease? I know that MCD is a rare disease. Mary is on predisone and other meds and was told to take Tylenol PM for the pain. She said that Tylenol PM really doesn’t help. Mary lives in Pickerington, Ohio (suburb of Columbus) and I’m wondering, do you know of anyone in Ohio who she could contact to include her in case studies and help her? I can take her to Ohio State or The Cleveland Clinic. Any information that you could provide me on medication and doctors names or places to take her would be greatly appreciated, Mary has been very depressed and can’t work now because of the swelling and pain. I would like to find some answers out there for her. Thank you for your time, Cindy Klimek