Welcome to the Chronic Kidney Disease Insider Newsletter. If you are living with chronic kidney disease (CKD) on dialysis, have had a kidney transplant or are helping care for someone who is, this newsletter was created for you and your family! The content is meant to keep you and/or a family member up to date on the latest information to help you manage your health now and in the near future in consultation with your physician.
In this month’s CKD Insider:
FINE-ONE Clinical Trial Recruiting Participants with CKD and Type I Diabetes
COVID-19 treatment Remdesvir approved for people with CKD on dialysis
Fabhalta Receives Accelerated FDA Approval for Treatment of Proteinuria in IgAN
Diality receives FDA 510(k) clearance for Moda-flx hemodialysis system
News from Kidney Organizations
NKF Michigan Kidney-PATH program to help you manage your CKD starts in September
The National Kidney Foundation (NKF) Michigan Personal Action Toward Health (Kidney-PATH) program is a 8-week workshop for participants who are in various stages of Chronic Kidney Disease. The first six weeks focus on overall healthy living, with two additional sessions that cover kidney specific content.
This informative and interactive virtual program starts with the Chronic Disease Self-Management Program developed by Stanford University for the first 6 weeks, the last 2 weeks were developed by the NKFM.
Next Information Session September 11
Sessions 1-8 starts September 18, 25
Wednesdays at 1:00-3:00pm
Learn more and sign up here
If you are new to dialysis for yourself or a loved one, you can learn more here and in the dialysis education section here.
RSN Video for people new to home dialysis
If you are interested in seeing real life examples of home dialysis, the Renal Support Network (RSN) video below gives you that personal perspective you might be looking for.
Your Fun Tip of the Day
Experience the Healing Power of Horses
Maintaining yourself on dialysis or caring for a family member who is on dialysis can be taxing. The goal is always to live with and not for dialysis. Spending time in nature and with animals can help you quickly change your mindset and bring you joy. If you are feeling particularly stressed spending time with horses can have a calming effect that transports you from your daily stresses.
Horses can sense how you are feeling and offer comfort in their own unique way. They also have personalities just like humans, so that when you connect with a horse it feels like a true bonding experience. Because of these reasons and others, horse therapy has become a common technique that therapists use to help people deal with stress, addiction, mental health and physical and developmental disabilities. The Professional Association of Therapeutic Horsemanship International (PATH Intl.) is dedicated to developing standards, credentials and providing education for professionals who use horses to support their clients.
If you have never been near a horse before or fear horses due to their size, you might be surprised what a calming effect they can have on you. Even if you don’t ride the horse, and just get to know a horse through simple interactions like grooming their hair, the calming effects will be clear. Since horses are like people with different personalities, finding the right horse for any long-term time together is important and you should look for a location that allows you that time. Places like therapy riding centers, equine therapy programs, and animal sanctuaries offer a chance to connect with horses in a supportive environment.
Learn more below and find equine therapy locations:
Healing Powers of Horses includes Equine Therapy Directory. Stella McCartney and The Chopra Foundation’s mental health initiative, Never Alone are raising awareness for how horses can support mental hygiene, facilitate healing and boost overall wellbeing through equine therapy and meditation.
Gallup NYC provides Therapeutic Riding- in NYC, Queens and Long Island, NY. The therapeutic horsemanship programs at GallopNYC provide measurable benefits for people with developmental, emotional, social and physical disabilities. Through weekly riding sessions with PATH Intl. Certified Therapeutic Riding Instructors, they teach new skills, inspiring each rider to live life as fully, productively and independently as possible.
Choosing a horse for equine therapy at Shepherds' Hill Academy
The Healing Powers of Horses article - author's first hand experience.
FINE-ONE Clinical Trial Recruiting Participants with CKD and Type I Diabetes
What it is: The FINE-ONE clinical trial is recruiting participants to determine how safe and how well finerenone works for those with chronic kidney disease (CKD) together with Type I Diabetes. Finerenone has already been approved for people with CKD and Type II Diabetes, this would be a Phase I trial to test the same drug for people with Type I Diabetes.
Why it’s important: People with Type I Diabetes produce reduced insulin, resulting in elevated blood sugar that can cause damage to the kidneys. For this reason, chronic kidney disease often occurs along with Type I Diabetes. Current treatment options are not sufficient for this patient population, and Finerenone is effective for Type II Diabetes.
If you are at least 18 years of age and interested, you can learn more and see if you qualify here.
Remdesivir is Safe for COVID-19 Treatment in Patients With Severe Kidney Impairment
What it is: A recently completed Phase 3 trial found that Remdesivir is safe for patients with severe kidney impairment who are hospitalized with COVID-19 pneumonia. The results of this study were published in Clinical Infectious Diseases.
Why it’s important: Remdesivir is an effective antiviral treatment for those hospitalized with severe COVID-19 and accompanying pneumonia. The country has seen a spike in COVID-19 cases this month. Because of reduced kidney function, some medications have not been used for chronic kidney disease patients. This trial confirms the safety of using Remdesivir for those with CKD hospitalized with COVID-19 pneumonia.
Related: The FDA has approved updated COVID-19 vaccines for the 2024-2025 season to combat current variants. Learn more about the updated vaccines here.
For people with CKD not on Dialysis: Fabhalta Receives Accelerated FDA Approval for Treatment of Proteinuria in IgAN
What it is: Fabhalta® (iptacopan), produced by Novartis, is the first complement inhibitor that has been shown to reduce levels of protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN). Fabhalta reduced proteinuria 38% more than placebo nine months after starting the trial. Though the trial isn’t over yet, given these exciting results, the FDA granted accelerated approval, which will be reevaluated after the next round of data are collected later on.
Why it’s important: IgAN is an autoimmune disease affecting the kidneys. More than half of people with IgAN advance to kidney failure within 10 to 20 years. So, there is clearly a need for therapeutics to treat this disease. Fabhalta is the first drug of its kind to address this rare but serious kidney disease.
Diality receives FDA 510(k) clearance for Moda-flx hemodialysis system
What it is: The Moda-flx hemodialysis system allows for flexibility in customizing dialysate for each patient and is easier to use, reducing clinic training time. The Moda-flx makes dialysate on demand for each patient, so clinics do not have to store bags of dialysate. It is also fully integrated with a dedicated cart and an integrated reverse-osmosis water filtration system so that it can be moved around a variety of facilities, with or without access to a central water system. Diality, the maker of this system, received FDA 510(k) clearance in August. A 510(k) application is required before any new product is marketed, and clearance indicates that the FDA believes the product is safe and as or more effective than other options on the market.
Why it’s important: Dialysis centers continue to have a shortage of qualified nurses and technicians to provide critical dialysis care. The decreased training time, ease of use, and ability to operate independently of a central water system help to address personnel and facility shortages. For patients, the ability to customize dialysate for each person – and to collect data for further customization – allows for better, individualized treatment. Currently, Moda-flx will only be available in clinical and center settings, but a clinical trial is being conducted to test it for home dialysis use. This would prevent home dialysis users from needing to store dialysate bags and could safely deliver hemodialysis even if there is disruption to a reliable water source.
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