Including People with Kidney Diseases in COVID-19 Trials: KHI Identifies Opportunities

People with kidney diseases should be included in COVID-19 clinical trials—especially vaccine candidates—as a crucial measure that increases “trust in the science and development process for the vaccine among kidney patients,” according to a recent statement of the Kidney Health Initiative (KHI). Including people with kidney diseases and kidney failure, as well as those with undiagnosed reduced kidney function, will ensure the efficacy and safety profiles of any vaccine candidate will be understood in people with kidney diseases, the statement says.

The KHI statement builds on an earlier statement that encouraged inclusion of people with kidney diseases in all COVID-19 clinical trials. The follow-up statement identifies ways to increase enrollment of these populations. “We found a broad range of inclusion and exclusion criteria of people with kidney diseases after reviewing the published protocols of the vaccine candidates currently in phase 3 trials,” said Raymond Harris, MD, FASN, co-chair of KHI and its COVID-19 response team. “It is important that we have data on this special population prior to widespread dissemination of a vaccine to ensure that those with kidney diseases who choose to be vaccinated can do so safely and obtain maximum preventive benefit.”

People with kidney diseases are a large part of the general population, at 37 million in the US and 700 million worldwide, and have an increased risk for developing severe complications from infection by SARS-CoV-2, the virus responsible for COVID-19. Minority populations and those impacted by social determinants of health represent a significant and disproportionate percentage of the 15% of the US population with kidney diseases, “further contributing to the disparities observed with the distribution of COVID-19 infection rates,” according to the KHI statement. “In addition, individuals with severe chronic kidney disease or kidney failure have an increased risk of exposure to the virus as they are disproportionately hospitalized or are in long-term care facilities.”

US Food and Drug Administration guidance encourages the inclusion of racial and ethnic minorities most at risk for infection, as well as elderly patients and those with medical comorbidities in COVID-19 vaccine development (1). KHI notes that all these groups encompass people with kidney diseases and calls upon all sponsors and investigators involved in current or planned COVID-19 vaccine trials to include this population, especially in phase 3 trials. Nephrologists are urged to reach out to their clinical trial colleagues to identify and encourage eligible kidney patients to participate in these trials.

Patient organizations that are members of KHI will be including resources that inform and educate their members on how to participate in COVID-19 vaccine trials, in consultation with their nephrologist and care team, within their ongoing clinical trial campaigns. “Participation will maximize our knowledge and ultimately benefits any public health vaccination campaign for people with kidney diseases,” KHI states.

Reference

1. 

Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry. (2020, June). Retrieved September 2, 2020, from https://www.fda.gov/media/139638/download'

October-November 2020 (Vol. 12, Number 10 & 11)