President Trump signed an executive order on July 10, 2019 to launch the US Department of Health and Human Services’ (HHS) Advancing American Kidney Health initiative. This order will direct federal agencies to increase treatment for individuals with early forms of kidney disease, enable greater access to kidney transplants, and shift the financial incentives for clinics and doctors to use other solutions than dialysis.
In 2017, kidney disease was the ninth leading cause of death in the US with approximately 37m Americans having chronic kidney disease and more than 726,000 with end-stage renal disease. Additionally, more than 100,000 Americans begin dialysis each year.
The Executive Order read:, “The state of care for patients with chronic kidney disease and end-stage renal disease is unacceptable: too many at-risk patients progress to late-stage kidney failure; the mortality rate is too high; current treatment options are expensive and do no produce an acceptable quality of life, and there are not enough kidneys donated to meet the current demand for transplants.”
Mark Rosenberg, vice dean for education and academic affairs at the University of Minnesota and the president of the American Society of Nephrology (ASN), is leading trials in developing greater renal care.
Through his work, ASN has also partnered with the HHS as a means of accelerating innovation in the prevention and treatment of kidney disease through its project, Kidney X.
Rosenberg said in a statement, "This has been many years of work trying to get to this stage; trying to get the upper echelons of the administration to really recognize kidney disease.”
As a member of the industry pushing for kidney care, Rosenberg attended the Administration’s signing of the Executive Order to which he said, "It was one of the most exciting days in my 35-year nephrology career. This administration is driving bold, comprehensive change by elevating kidney health and prioritizing the prevention, diagnosis, and treatment of kidney diseases to slow progression. This new strategy re-aligns priorities, practices, and payments to better achieve kidney health for all people."
Rosenberg also said that he expects this policy will change incentives that will help nephrologists focus attention on upstream work for kidney health.
"The strategy outlined [per the Executive Order] includes both shorter-term objectives and policy changes will help more patients today and longer-term strategies that will fundamentally transform kidney therapeutics," said Rosenberg.
Expanding research opportunities
After the Executive Order was signed by President Trump, DaVita Kidney Care made a statement demonstrating its appreciation for the current Administration’s willingness to collaborate with the pharmaceutical industry to ensure growth in renal research and care.
DaVita said its focus is on developing patient-centric care models and using technologies to provide integrated care offerings for its patients.
Across the US, renal research has been expanding across the US, as researchers aim to gain a greater understanding of the disease and potential treatments, and connecting patients to trials and centers have enabled greater patient recruitment
The contract research organization (CRO), Frenova Renal Research, a division of Fresenius Medical Care North America, and the American Renal Associates, have established site networks aimed at accelerating clinical trial enrollment for kidney disease trials, expanding research opportunities for patients.
Frenova has more than 260 sites with over 450 principal investigators across the US. It also launched the F1RST UP (Frenova Rapid Start Up) alliance in late 2018 to expedite the startup of clinical trials for the treatment of renal disorders.
Additionally, the American Renal Associates created its investigative site network in 2018 to expand research by providing physician partners and sponsors the ability to reach kidney care patients.
From a regulatory standpoint, the FDA has been calling for greater inclusivity in eligibility criteria to expand patient participation in trials. As such, the agency published four draft guidance’s and one final guidance addressing trial legibility criteria for cancers that often exclude specific patient populations, such as individuals with co-current conditions.
Per the guidances, patients with concurrent conditions, such as organ dysfunction, renal, cardiac, and hepatic dysfunction, are to be included in trials after pharmacokinetic (PK) and pharmacodynamic (PD) testing is concluded. With this guidance, a greater patient population will be able to access clinical trials as care, including those with renal diseases.
Home dialysis trial
CVS Health announced it will initiate a clinical trial on July 17, 2019 to evaluate the safety and efficacy of HemoCare Hemodialysis System for home hemodialysis administration for renal patients.
The clinical trial is set to enroll 70 patients and will be conducted across 10 sites in the US and will be led by CVS Kidney Care, a division of CVS Health. CVS Kidney Care is also working to meet the objectives set out by HHS to expand treatment options for kidney disease.
The home hemodialysis administration system meets the Executive Order’s push for care that enables patients to have a more acceptable quality of life, as the patients can administer treatments at home.
“For those patients who do progress to dialysis, we are working to bring a new solution to the consumer that addresses the current barriers to and limitations of existing dialysis options, and we’re working closely with the US FDA as we evaluate this device,” said Alan Lotvin, EVP and chief transformation officer at CVS Health.
CVS Health said that home hemodialysis may also help facilitate longer, more frequent dialysis treatments as compared to in-center treatments and result in better health outcomes in certain patient populations. The system was developed in collaboration with DEKA Research and Development Corporation.