I’m way overdue for an update here on what I’ve been up to over the past several months. I’m happy to report that things have been, well, quiet. Good quiet. With the gradual opening of the state after the lockdown, I’ve done a good job of minimizing my exposure to others for the most part. In spite of the pandemic, I haven’t exactly been standing still.
The Latest Vital Signs
My kidney function – knock on wood – continues to stay stable. It’s even ticked up a little from stage four to stage three territory. While it’s not a big jump in terms of numbers, it is significant for one reason I’ll get to shortly.
Blood pressure remains very good. If you’re new to kidney disease, this is one of the primary goals of kidney care. Proper blood pressure management is a key towards extending the life of your kidneys. Even if you don’t have kidney disease, I recommend that people getting into their 40s and above get in the habit of monitoring their own blood pressure (you can get very affordable machines at pretty much any drugstore these days). If it’s high, get checked out now. You may feel fine, but high blood pressure is the canary in the coal mine. It’s a hint that something very serious is on the horizon even if you feel no symptoms now. The first time I started getting high blood pressure readings at the doctor’s office, I didn’t take it as seriously as I should have. Looking back I now know this was when my kidneys were being damaged extensively. Being proactive with your blood pressure is the key to avoiding stroke, heart attack, and life threatening organ damage down the road. Don’t ignore it!
Taking The Leap
With that public service announcement out of the way, it wasn’t all boredom and isolation during the latter part of the summer. I’ve actually been keeping myself quite busy. For my tens of readers who might recall in my Quarantine Edition update, I mentioned I would be taking part in a screening test to determine my eligibility for one of the clinical trials. I also mentioned that I didn’t feel confident that I would make the cut because of concerns that my eGFR and Albumin/Creatine Ratio numbers wouldn’t be high enough.
Well, what’s got two thumbs and totally aced the test? This guy!
It was close, but long story short, my eGFR and proteinuria numbers in the end were just high enough. The jump in eGFR I referenced earlier paid off at just the right time. In every other way I’m actually an ideal candidate for this trial. I don’t currently have other conditions that put me any more at risk, and overall I’m pretty healthy for someone with my illness – knock on wood.
The trial I was accepted into was the Omeros OMS721 study which is now in phase three and has reported some positive feedback. The drug in question is called Narsoplimab and while I won’t attempt to explain exactly how it works I will provide resource links at the end of this article for those interested in learning more. For the rest of this article I want to briefly describe the process I went through to get where I am now. I will also take some time to stress why these clinical trials are so important, and what you can do to help move them forward.
My journey began with a trip to the kidneyhealthgateway.com website where they compile many of the clinical trials and other studies dedicated to kidney disease. I eventually tried out for the OMS721 for Patients with IgAN study, primarily because the little I did hear about it was positive. More importantly, the study has a location that is not only local to me (in the Boston area), but it is being conducted at Tufts Medical Center where my nephrology team is. Being able to schedule my study visits and my nephrologist appointments on the same day is a nice side benefit. It’s also nice that should there be any complications, the two teams can work together to iron things out.
Once I applied online, a coordinator got back to me and scheduled me for a screening test. This is where they perform the initial tests to make sure you meet the necessary criteria to be accepted. Each study has at least slightly different requirements, but for this I needed to make sure my eGFR was at 30 or above and that my other vitals were relatively healthy. Conditions like poor cardio health and other comorbid conditions could potentially disqualify candidates from participating, so it is at this early phase where they start deciding who the potential candidates are. As I mentioned before, my eGFR was borderline at first, but by the time of the screening I had gotten myself over the hump. Fortunately my blood pressure and EKG readings were excellent.
The run-in phase was where I had to submit a twenty-four hour urine test (two days worth actually). It’s a bit of a drag for a couple days, but it’s not the end of the world either. The purpose here is to get an accurate figure of how much protein is being spilled. For the purpose of this study, that needs to be at least one gram. This too was a borderline figure for me, but once again I made it just over the wire.
After completing the run-in phase (for some people this requires four visits while for others it only requires two – in my case I only needed two), I moved on to the treatment phase which is where I am now. As of this writing I just had my first infusion and will repeat this process for the next eleven weeks (twelve altogether). Since this is a double-blind study, I don’t know if I have the placebo or the real thing nor do the coordinators at Tufts, but hopefully the follow up labs at the conclusion of the twelve visits will provide some clues.
Narsoplimab is currently being studied for a number of potential treatments, including Covid-19 among others. In my case it is being tested as a treatment for reducing proteinuria which if successful will go a long way towards extending kidney life. In layman’s terms, it blocks out the system that initiates the inflammation from IgA flareups. I won’t try to describe it in medical terms. I kind of get what it does, but I could never fully explain it.
So Why Do It?
Everyone has their own reasons for why they choose to take part in clinical trials or choose not to. I can only explain why I do it and why I feel you should consider it if you are also a patient.
First, you have to consider the current state of treatment for IgA Nephropathy, FSGS, and other rare diseases that cause kidney damage. Outside of blood pressure management and for more severe cases steroids and immunosupression medication, there really is nothing. Not only is there no cure, there is no medication specifically targeted for these diseases to even treat them.
If there are going to be any advancements in the treatment of rare diseases it’s going to have to be driven by the patients and caretakers working with the medical community. The blunt truth is, rare disease patients are not very profitable. That is, until they end up on dialysis, at which point a few companies make a lot of money. It costs a lot of money to invest in potential cures and treatments for what is considered a limited customer base. It will always be this way until we change the way we incentivise health research.
Twenty years ago there wasn’t a single clinical trial available and advancing our treatment options didn’t appear to be on the horizon. That began to change when patients and parents of patients decided to come together to do the work that nobody else would. Along came organizations like Nephcure Kidney International and the IgA Nephropathy Foundation of America who spearheaded efforts to inform the public of our existence. At the same time they ran fundraising campaigns that would help further research into potential treatments specifically targeted towards protein spilling diseases.
This process took time and was a lot of work, but we are now finally starting to see results on the horizon. Today there are over twenty medications in various phases of development and more on the way. The early results for some of these medications give us reasons to be optimistic, but there is still a lot that needs to be done.
This is where we the patients come in. In order to complete these trials (and complete them faster), it is imperative that a large number of qualifying patients are involved in the testing phases. It’s the quickest way to push the process forward and this is a need that only patients can fulfill.
The sooner we can get these treatments to market the better our chances of helping patients delay and possibly eliminate the need for dialysis. The more we can keep people off the transplant list the better the odds are for everyone faced with kidney failure.
So in the end I do it because as a patient I want to be a part of what ultimately becomes the solution in whatever small ways I can. This is just one of those ways. Volunteering for a clinical trial is not a strain on my life. In fact I typically look forward to my visits. When you’re a patient dealing with a life altering illness, you don’t want to feel passive or useless. Since I’m not too sharp when it comes to medical knowledge, volunteering gives me an avenue to be an active participant in my outcome.
It also helps that there is a chance I am taking a medication that could potentially extend the life of my kidneys. Avoiding dialysis and delaying time to transplant is key.
If you are a patient, I’m also asking to consider taking part in a clinical trial in your area. If you qualify, you may end up getting an immediate benefit from having potential access to drugs before they are approved by the FDA. This is important for us because as I’ve already mentioned, we don’t currently have any of these medications on the market. If you get the placebo, you’re still helping to move the chains forward for the necessary research and you might even be able to get the real medication for a period after the initial treatment phase is completed. If you have the transportation and can commit a little time each week (the amount of time required will differ for each trial) there is really no reason not to at least take the screening test to see if you qualify. This is by far one of the best ways we have of empowering patients.
If this sounds like an opportunity you would like to look further into, I’m going to list a few resources below. If you are interested in taking part in the Omeros OMS721 study here in Boston, feel free to reach out to me via email at firstname.lastname@example.org and I can refer you to the right people to get you started. I will also be glad to try and answer any questions you may have pertaining to the trial and if I don’t have the answer I’ll try to at least point you in the right direction.
Otherwise the official link to sign up for the OMS721 study is:
Further information on this trial:
- Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
- NKF – Artemis-IGAN A New Trial For Eligible Patients With IgA Nephropathy
- ScienceDirect: Safety, Tolerability and Efficacy of Narsoplimab, a Novel MASP-2 Inhibitor for the Treatment of IgA Nephropathy
As I mentioned before, the OMS721 trial isn’t the only game in town. There is a varietty of trials out there targeting IgA, FSGS, Minimal Change Syndrome, and others. Check out some of the links below to get an idea of what’s out there and how to get involved:
- Nephcure Kidney Health Gateway
- IgA Nephropathy Foundation of America Clinical Trials Page