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:
News from Kidney Organizations
Online Support Groups
Listening and learning from others in the same situation can really help you as you navigate dialysis. If you are looking for communities to join where you can share your experiences or ask a question sometimes in the middle of the night, check out the groups below or start your own group! If you have a favorite group let us know and we will include in future newsletters.
AAKP Webinar
National Gout Awareness Day: A Closer Look at Gout and the Kidney Disease Connection May 22, 2024 3:00 pm ET
Register here
Home Dialysis Central Webinar
Your Voice Matters Webinar - Talking with your dialysis team
Outset medical is sponsoring this event
May 28th, 2024 7:00 pm ET
Register here
RSN Monthly Support Group
Renal Support Network's Support Gruop meets the 4th Sunday and 2nd Tuesday of the month. "Finding support beyond that offered by family and friends can help you cope with the life changes of kidney disease. People who attend RSN’s support group share their experiences, strength and strategies to live a hopeful and joyful life." Their next meeting is below.
May 14, 2024
2:00 - 3:30pm PT
Register here
Your Fun Tip of the Day!
Take a RoadTrip!
The days are getting longer, summer is almost here, are you feeling the itch to take a trip and get out of town? Now is the time to start planning that trip. Even if you can't go far any change of the scenery is a great distraction, and before you know it you will be smiling and enjoying the moment!
Vafseo® received FDA approval for the treatment of anemia caused by CKD for patients receiving dialysis
What it is: On March 27th, vadadustat (Vafseo) received FDA approval for treating anemia in adult patients with CKD on dialysis who have experienced anemia for at least three months. Vadadustat has already been approved by 36 other countries, beginning with Japan in August 2020.
Why it’s important: About 500,000 people with CKD on dialysis experience anemia. The most common treatment for anemia caused by CKD is erythropoiesis-stimulating agents (ESAs), along with iron supplementation. Vadadustat is a prolyl hydroxylase inhibitor that takes a different approach to stimulating the production of red blood cells. Clinical trials determined it was just as good as ESAs at elevating hemoglobin levels but better at improving other factors influencing anemia, such as increasing the concentrations of serum erythropoietin (EPO).
What to do: If you are on dialysis and ESAs have not been helping with your anemia, speak to your nephrologist to see if Vafseo is right for you.
Read more about this approval from Akebia (the drug manufacturer) or the American Journal of Managed Care (AJMC).
Fresenius issues recall of Stay-Safe Catheter extensions and adapters used for peritoneal dialysis
What it is: Fresenius has issued a recall of its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters after non-dioxin-like (NDL) polychlorinated biphenyl acid (PCBA), or NDL-PCBA, was found to be leaching into the dialysate where it can enter the patient’s peritoneal cavity. For patients over 40kg or 88 lbs, the levels of NDL-PCBA exposure are within acceptable ranges. However, for people who weigh less than 40kg, including pediatric patients, alternatives should be used. If an alternative is not available, it is recommended that the shortest length extension set be used to reduce exposure.
What it is important: The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
What to do: If you receive peritoneal dialysis, check whether you or your healthcare facility use any of the impacted products (listed below). For patients over 40kg or 88 lbs, you don’t need to make any changes. The levels of NDL-PCBA exposure are within acceptable exposure ranges for most adults. However, alternatives should be used for those who weigh less than 40kg, including pediatric patients. If an alternative is not immediately available, DO NOT skip dialysis. Instead, limit exposure by using the shortest length extension set (6-inch) and avoid using the adapter, if possible.
Impacted products:
If you have questions, you can contact Fresenius Medical’s Global Medical Information and Education Office at 855-616-2309 and read the full recall here.
Outset Medical, Inc. Recalls Certain Tablo Hemodialysis Systems for Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBAs
What it is: Outset Medical, Inc has issued a recall of the Tablo Hemodialysis System, which is used for the following treatment types: intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED/ SLEDD), prolonged intermittent renal replacement therapy (PIRRT), and isolated ultrafiltration.
The recall is due to leaching of non-dioxin-like polychlorinated biphenyl acids (NDL-PCBAs) from the peroxide cured silicone tubing used as a part of the machine’s hydraulics and for the dialysate lines. Patients may be exposed to higher than allowable limits of these NDL-PCBA compounds via the dialysate solution.
Why it's important: The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. This was originally reported in March.
What to do: If you are using new Tablo Hemodialysis System(s), consider using other alternative machines, if any are available. Read here for more details on next steps.
Contact Outset’s Technical Support team (844-MYTABLO or 844-698-2256) with any questions.
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