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The CKD Insider                     September 2021 Recap
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: NKF/ASN race-free approach to estimate GFR, AKF Kidney Action Week & Hurricane Ida relief fund, new kidney transplant advocacy group, mental health and dialysis workers, Korsuva approval for severe itching, kidney transplant rejection testing, The Kidney Project artificial kidney milestone, and the Fun Tip of the Day!

 
NKF & ASN joint task force recommends a race-free approach to estimate GFR
The estimated glomerular filtration rate (eGFR rate) is an important calculation doctors use for detection, diagnosis and management of kidney diseases.  The equations used for the eGFR calculation take into account serum creatinine levels (from a blood test), age, sex, body type and race. The NKF-ASN Task Force was formed to evaluate the inclusion of race in the eGFR calculation and its implications for the diagnosis and subsequent management of patients with, or at risk for, kidney diseases.

This month the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) joint task force released a joint report that included new recommendations for evaluating kidney function. In the report, the NKF-ASN Task Force recommends the immediate inclusion of the new criteria highlighted below by healthcare facilities as well as 8 areas for future investigation.  

  • Immediate adoption of the "eGFR 2021 CKD EPI Refit creatinine equation" that estimates kidney function without a race variable.
  • Increased use of cystatin C combined with serum (blood) creatinine to confirm eGFR in adults at risk for or who have CKD.
  • More research on GFR estimation with new endogenous filtration markers and on interventions to eliminate race and ethnic disparities should be encouraged and funded.

References: A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. Journal of the American Society of Nephrology (ASN), and the American Journal of Kidney Diseases (NKF). September 2021, Reassessing the Inclusion of Race in Diagnosing KidneyDiseases: An Interim Report From the NKF-ASN TaskForce, Reviewing Race and Kidney Disease in the NKF-ASN Task Force Report, interview with Susan Quaggin, MD, FASN, current ASN president.
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The American Kidney Fund (AKF) Kidney Action Week conference videos are available now.
The American Kidney Fund Kidney Action Week virtual conference included speakers from various backgrounds including nephrologists, people with CKD on dialysis, and those who have had a kidney transplant. If you want to learn about any of the topics below click the link above to watch the videos on the topic of your interest.

AKF Kidney Action Week Agenda:
Monday topics: "Finding Answers for the Unknown Causes of Kidney Disease: A Roadmap for Change", "Hypertension, Diabetes and Kidney Disease: Understanding the Connection","The Importance of Clinical Trials: Why Participant Diversity Makes a Difference"
Tuesday topics: "Home Dialysis and the Patient Experience: Could Home Dialysis be for You?","Know Your Kidney Health Care Team: Effective Communication for the Best Health Outcome", " Living with Stage 3 Kidney Disease"
Wednesday topics: "Ask a Nephrologist: Audience Q&A with Dr. Akhtar Ashfaq","Congressional Briefing: Increasing Kidney Transplants in Communities of Color", "Ask a Nephrologist: Audience Q&A featuring the “Cooking Doc” – Dr. Blake Shusterman"
Thursday topics: "Gout & Kidney Disease", "All About ADPKD (Autosomal Dominant Polycystic Kidney Disease)", "The Kidney Transplant Process: What You Need to Know"
Friday topics: "Living Well After a Kidney Transplant", "Kidney Disease & Mental Health"
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AKF Relief Fund for people with CKD affected by Hurricane Ida is available
Louisiana dialysis and recent kidney transplant patients who need emergency financial help should contact a social worker at their dialysis clinic for information on applying for aid or submit an application directly at gms.KidneyFund.org. There are also Non-financial resources for people with CKD affected by Hurricane Ida available.
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Assistance to help with the mental health of dialysis center personnel available
ASN created the Pursuing Mental Wellness program to help the dialysis facility staff take the best care of you and your loved ones. The program addresses the impact of COVID-19 on dialysis facility staff, and provides tips and strategies for combatting compassion fatigue.
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Kidney transplant advocacy group launches
The Kidney Transplant Collaborative (KTC) is a new national nonprofit organization and advocacy group dedicated to increasing kidney transplants while decreasing financial obstacles and other common challenges that kidney recipients and donors experience during the kidney transplant process.
Plant some flowers and brighten everyone’s day!

Gardening is a great mood boosting activity that can bring out your creativity in ways beyond the act of gardening and bring joy to everyone’s day!  Whether you only have space indoors or have access to a lot of outdoor space in your home or a community garden, growing a plant, flower or tree can be an enjoyable and therapeutic activity you can do all year round alone or with company.
If you noticed your neighbor's front yards, balconies or windows adorned with more flowers and plants than typical since the pandemic, this might be an opportunity to ask them about it, it's possible like many others during the pandemic they found a new hobby to help them pass the time and improve their mental health during this time and they might be happy to share some tricks they have learned!
Cara Therapeutics in partnership with Vifor Pharma receive approval for drug to alleviate severe itching in adults with CKD on hemodialysis.

What it is: The FDA has approved difelikefalin (brand name: Korsuva (TM) injection for the treatment of moderate-to-severe pruritis that is associated with chronic kidney disease (CKD).

Difelikefalin works by activating the kappa opioid receptor (KOR) found on neurons and immune cells. This activation results in reduction of pain and itch.  A total of 1306 people on hemodialysis with moderate-to-severe pruritus were treated with KORSUVA in both the US and globally. Of these, 711 were treated for at least 6 months and 400 were treated for at least one year. The drug is designed to be administered three times a week after each dialysis. Additional details and prescribing information for Korsuva can be found in the references section.

Note: Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.


Why it’s important to you: If you or someone you know is experiencing pruritis associated with CKD, this treatment could help alleviate those symptoms.  Many patients experiencing pruritis report disrupted sleep or depression associated with their symptoms.  Consult your healthcare providers to determine whether difelikefalin can help improve these symptoms.

References: FDA Approval Letter, Prescribing Information
 
Three kidney rejection tests launched or updated this month are reviewed below. All three tests can detect early kidney transplant rejection, giving healthcare providers additional time to proactively work to avoid loss of your kidney.  Important differences include sample collection, biomarkers measured, and Medicare coverage details.  There has not yet been a direct side-by-side comparison of the sensitivity of each of these tests. Discuss these options with your nephrologist to determine which tests are best to monitor your risk of kidney allograft rejection.

Prospera™ with Quantification by Natera
What it is:  A blood test for kidney rejection that to date is the only cell free (cfDNA) test that provides three values in one report: the quantity of donor-derived cfDNA (dd-cfDNA), the fraction of dd-cfDNA and total cfDNA. 

This test is an improvement over the previously marketed Prospera test that measures dd-cfDNA as a percent of total cfDNA. Natera found that total cfDNA can become elevated during viral infections and other changes in the recipient, which can lead to false negatives and decided to improve on the original Prospera kidney rejection test. The validation study data supporting this improved test included 41 patients, and a full multi-site prospective study has been completed and the data is targeted to be published in early 2022.

Prospera™ is now covered by Medicare for first-time renal allograft recipients who have undergone physician assessment to evaluate the likelihood of renal allograft rejection.

OmniGraf™ by Transplant Genomics
What it is: A blood test for kidney rejection that combines the TruGraf® gene expression test with the Viracor TRAC® donor-derived cell-free DNA test.

OmniGraf combines these two tests to provide a comprehensive view of both the subclinical acute rejection (by looking at the expression of 107 inflammatory genes before visible clinical indications) and the clinical acute rejection (looking at the amount of donor’s DNA in the blood). This comprehensive view has a high positive and negative predictive value.

OmniGraf will be reimbursed for kidney transplant recipients covered by Medicare. If you have private insurance Transplant Genomics will work with your medical care team to receive prior authorization for OmniGraf.


QSant™ by NephroSant
What it is: NephroSant developed the first at-home biomarker test for kidney rejection that uses urine rather than requiring a blood sample. QSant™ measures 6 biomarkers and uses additional post-transplant information to create a quantitative QScore™ that indicates the risk of rejection. This test was just issued a local coverage determination allowing the charges associated with this test to be covered by Medicare.

What these new and improved testing options mean for you: Improved accuracy of tests for earlier detection of kidney rejection means your nephrologists will get this information in advance of a rejection event allowing them to act proactively to help keep your donated kidney healthy for as long as possible. Additionally, the convenience of at home testing or blood sample testing with minimal volumes allows you to be tested more often in a non-invasive manner (versus having an invasive biopsy), which means you can stay ahead of any potential kidney rejection events before it becomes clinically obvious.

References: Natera Launches Prospera™ Kidney with Quantification to Further Improve Test Performance, Demonstrating Commitment to Innovation in Transplantation, Transplant Genomics Launches OmniGraf™, the Only Combination Biomarker Panel That Provides the Earliest Indication of Rejection in Kidney Transplant Recipients, NephroSant Secures Medicare Coverage for QSant, the First Urine-based Kidney Transplant Rejection Test.
 
What it is: The Kidney Project, a recent Kidney X Prize recipient, has created a functional bioartificial kidney prototype. This device is engineered to provide people in need of a new kidney an alternative to dialysis and transplantation of a donor kidney. The implantable device would mimic the function of a transplanted kidney minus the need for immunosuppressant medications.

The bioartificial kidney consists of two parts to replicate normal kidney function: a mechanical filter called a hemofilter and a bioreactor that contains live, lab-generated renal tubule cells. The filter removes contaminants from the blood while the live renal cells housed in the bioreactor maintain the proper blood composition including electrolyte balance and water volume. The hemofilter membrane also protects the live cells from the person’s immune system so that they are not vulnerable to rejection.

The Kidney Project researchers at University of California San Francisco (UCSF) and Vanderbilt University, recently tested a prototype of their bioartificial kidney. In in vitro (in cell) studies, the prototype was able to be powered by blood pressure alone without the need for anti-coagulants or external power sources.  The cells housed in the bioreactor remained alive over the course of the studies. Previous tests had evaluated each of the components separately, but this was the first time they were tested together successfully. The prototype is a scaled down version of the proposed device.

Why it’s important for you: This milestone test of the bioartificial kidney with both test together is an important example of the advancements being made to improve the lives of people with CKD. While this still needs to be tested in vivo in preclinical animal models and subsequent clinical trials, if successful, the bioartificial kidney would eliminate the need for dialysis and would also address the shortage of viable organs for those who require kidney transplantation. Unlike transplantation, the bioartificial kidney would not require the use of immunosuppressive drugs.

Reference: The Kidney Project successfully tests a prototype bioartificial kidney. Image credit: UCSF

 
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