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! 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: FDA authorization of 3rd dose of SARS-CoV-2 mRNA vaccine, NIH SARS-CoV-2 transplant study, Advocacy Alert, FDA approves Kerendia medication & Pfizer-BioNTech COVID-19 Vaccine, Recent research, and the Fun Tip of the Day!
COVID-19 and kidney transplant recipients
FDA authorizes additional COVID-19 SARS-CoV-2 vaccine dose for solid organ transplant recipients and those who are immunocompromised.
The FDA has authorized an additional COVID-19 SARS-CoV-2 vaccine dose for certain immunocompromised people. The CDC also recommends people who are moderately to severely immunocompromised should receive an additional dose of mRNA COVID-19 vaccine after the initial 2 doses.
FDA authorization details: The authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine to individuals 18 years of age or older (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
NIH launches new study: COVID Protection After Transplant (CPAT).
The NIH launched a study to evaluate the effects of a third COVID-19 dose in kidney transplant recipients titled: COVID Protection After Transplant (CPAT).
If you would like to be part of this study, you can enroll by contacting Johns Hopkins University using the email address email@example.com. More information about the trial is available at ClinicalTrials.gov under study identifier NCT04C969263.
Randomized trial of third dose of Moderna SARS-CoV-2 vaccine in organ transplant recipients.
The University Health Network in Toronto, Canada conducted a double-blind, randomized, controlled trial of a third dose of mRNA-1273 vaccine (Moderna) as compared with placebo. 120 organ transplant recipients were enrolled. The data agreed overall with what other research groups reported (see June CKD Insider) - a third dose of mRNA vaccine in transplant recipients was safe and resulted in a higher immune response than the placebo groups.
Reference: Randomized Trial of a Third Dose of mRNA-1273 Vaccine in Transplant Recipients. New England Journal of Medicine August 2021.
Your input requested on the CMS 2022 Proposed Rule for ESRD
Home Dialyzors United Group (HDU) has drafted a response to the recent CMS 2022 Proposed Rule for ESRD. If you or your family member dialyze at home you should read and if agree sign the HDU response letter. You can add your comments in support of any or all of the issues that HDU is asking CMS to address. Be candid and tell them what you want. This is your opportunity to be heard!
Your Fun Tip of the Day!
Create a memory book for your wall! A picture is worth a thousand words. To continue the photography theme from the last newsletter, you might now be realizing you have a lot of incredible photos that you don’t want to stay hidden in a folder in your computer or in a cabinet in your home. Take your favorite pictures – the ones that make you automatically smile or give you a warm feeling, and create a photo collage. You can create collages with themes, like an incredible trip you took to another country or just your favorite family and friendship moments. Use as many or as few pictures as you like. A few collages will help keep those memories and experiences alive and readily available to you. These days photo collage making tools are easy to use and often free. Check out a few examples below or find your own tool that works best for you! CVS Photo Center – Pre-set collage layout options, and easy ordering of finished prints Google Photos - Free built in collage maker Fotor Collage – Free basic features and pay for advanced templates Canva Collage Templates – Many collage formats that are categorized by theme
Recent FDA Approvals
Bayer’s Kerendia (Finerenone) delays chronic kidney disease progression associated with type 2 diabetes. What it is: The FDA approved Kerendia (finerenone) tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. The efficacy of Kerendia to improve kidney and heart outcomes was evaluated in a randomized, multicenter, double-blind, placebo-controlled study in 5,674 adults with chronic kidney disease associated with type 2 diabetes. Kerendia works by blocking over activation of the mineralocorticoid receptor (MR). Over activation of the mineralocorticoid receptor is thought to contribute to fibrosis and inflammation which can result in permanent structural kidney damage. More details on the mechanism of action can be found in 12.1 of the Prescribing Information here. Why it’s important to you: If you have type 2 diabetes and have seen a reduction in your kidney function this medication could help slow down chronic kidney disease progression and reduce your risk for cardiovascular events. Speak with your physician to see if this medication can help you preserve your kidney function.
The Pfizer-BioNTech COVID-19 vaccine gets FDA approval for the prevention of COVID-19 disease.
The FDA approved the Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older. This FDA approved vaccine will now be marketed as COMIRNATY. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Research Leading the Way
What it is: A genome-wide association study that pinpoints new target genes, cell types, and mechanisms for treating chronic kidney disease.
Researchers at the University of Pennsylvania Perelman School of Medicine analyzed the gene expression patterns and genetic variations in 659 human kidney samples. The authors utilized a single cell sequencing method that allowed them to identify 182 genes likely responsible for kidney function and 88 genes for hypertension. This study also clarified the mechanism of commonly used antihypertensive and renal-protective drugs and identifies drug repurposing opportunities for kidney disease.
What this means for you: This recent publication adds to the growing body of literature focused on kidney health and disease. The combined learnings provide opportunities to advance new treatment options and improve care for you or your loved one in the future.
Reference: Mapping the genetic architecture of human traits to cell types in the kidney identifies mechanisms of disease and potential treatments. Nature Genetics August 2021, Penn Medicine News Release.
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