Exploring What’s Possible With COVID-19 Trials and Kidney Disease

Could dialysis centers become sites for patients with kidney disease to become clinical trial participants?

During the American Society of Nephrology’s (ASN) Kidney Week, a panel discussed that and other ideas about how the nephrology community is coping during the ongoing coronavirus disease 2019 (COVID-19) pandemic and how they are sharing knowledge to help patients.

“Hopefully everyone is aware that COVID-19 has had an enormous impact on the kidney community, on patients and their families, as well as providers,” said moderator Raymond Harris, MD, FASN, co-chair of the Kidney Health Initiative (KHI) and a professor of medicine at Vanderbilt University.

Founded in 2012, KHI is a public-private partnership between the ASN, FDA, and over 100 companies, developers, and organizations in renal disease. Most of the panel speakers were also KHI members:

• Paul Conway, chair of policy and global affairs and immediate past president of the American Association of Kidney Patients
• T. Alp Ikizler, MD, FASN, chief of nephrology at Vanderbilt University
• Patrick Nachman, MD, FASN, chief of neurology at the University of Minnesota
• Uptal Patel, MD, a research scientist at Gilead Sciences
• Amy Young, vice president at DaVita Clinical Research

Harris started out by noting that acute kidney injury (AKI) occurs in up to 5% of all hospitalized patients with COVID-19; many of whom will need dialysis. The incidence soars to between 50% and 90% for patients in intensive care units. Those with kidney diseases show anywhere between a 2- to 16-fold increased risk for developing severe symptoms if they developed COVID-19, studies indicate.

Both KHI and the ASN COVID-19 Response Task Force worked as the pandemic started to emerge to release information and guidelines about the impact on those with kidney diseases, based on what was first seen in Italy and Spain. The first person to die in the United States was someone in a long-term care facility on dialysis, noted Ikizler.

Then, in a similar manner, as nephrologists in Minnestota saw what was happening in New York and New Jersey in March, the practices started banding together to make plans for a surge in the Midwest, including sharing equipment as well as providers, said Nachman.

“It was a grassroots phenomenon that was very unique,” he said.

The urgency of the pandemic and the need to care for people still needing dialysis treatments 3 times a week created collaborations that did not exist before, noted Young. In addition, she said “clinical trials are having their moment in the sun, and hopefully in kidney care that will sort of continue to happen. I think it's highlighted a gap in the kidney community, in terms of really understanding how to think about clinical trials in ways that are outside of the typical way that we engage with patient populations and with physicians.”

As examples, Young said DaVita conducted an awareness campaign for nephrologists to tell them that renal disease was not an exclusion for some vaccine clinical trials, sent physician letters, and reached out to patients through letters, social media, and other channels.

Roy asked Patel, "What do you think may be some opportunities for more innovative trial design that we may be able to see in the future so that nephrologists can really participate in a seamless way, as Amy was talking about?”

Historically, over 80% of cancer trials and over 50% of cardiovascular trials exclude patients with kidney diseases, Patel noted. The most common reason for that is concern about possible nephrotoxicity or adverse events, or because the patients with these underlying diseases have had a greater number of adverse events. Sometimes patients with mild or moderate kidney diseases are excluded from trials without a pharmacologic basis.

As a result, this patient population is not used to being asked to participate, he said.

On the other hand, Conway, who was on dialysis for years himself before receiving a transplant, also reminded the panel that patient participation in trials has a long, at times unsavory, history, starting with the infamous Tuskegee syphilis trials of Black men in the 1930s.

Another barrier, he said, is one of “nomenclature, which is, what is it exactly that's being asked of me? And what exactly is the risk to me and to my family, in talking in plain language?”

Peer-to-peer communication works best, and physician-patient conversation has to flow both ways, he said.