PKD Life - Fall 2020 - 23

evaluation, including an MRI.
Of course, asking someone
with a chronic illness to get on
an airplane was impossible.
Meanwhile, the third group
is currently scheduled for its
evaluation in the fall. In late
August, Dr. Nowak received
approval for the study participants to return, and for
recruitment to begin for the
time-restricted feeding study.
Balancing the need for
safety against the need to

fulfill grant requirements
"has been one of the biggest
things I've been wrestling
with." But, she says, the most
important thing is the health
of the study participants.

THE FALCON STUDY

Stephen Seliger, M.D., directs
the Baltimore PKD Center
Clinical and Translational
Core at the University of
Maryland School of Medicine.
He is also an active researcher,

with several grants from the
National Institutes of Health
as well as the pharmaceutical industry.
When COVID-19 hit, Dr.
Seliger was just gearing up for
a multicenter, phase 3 clinical trial known as FALCON,
which is investigating bardoxolone methyl as a treatment for PKD. Bardoxolone
has been studied for about
a decade in treating several
diseases, including kidney

disease. "It has some interesting effects on kidney function
that could be effective in
PKD," he says.
The FALCON study has
been on a pause in new
enrollment since late March.
"All clinical research deemed
noncritical that involved
any direct patient contact of
any kind was put on pause,"
Dr. Seliger says.
"It's been very difficult," he
adds. "We were involved in
a number of trials and it was
a huge scramble to do what
we had to do to shut down.
I understand the rationale
for this, having seen really
sick COVID patients up close.
But if you're in the middle
of clinical trial and a certain
proportion of participants go
off the study drug without
follow-up for several months,
it has huge implications for
the feasibility and interpretation of the data."
Still, he says, "We're not
throwing any data out. But
we will have to come up with
various sensitivity analyses to
understand how the missing
data and missed treatments
could affect the outcomes."
Study participants "have
been very understanding and
as flexible as they can be,"
Dr. Seliger says. In some cases,
they've received follow-up lab
testing at a commercial lab.
Dr. Seliger is waiting for
guidance on restarting his
studies. "There's no question
that COVID makes research
more complicated in the near
term," he says, "but in the
long term, there is a strong
sense of commitment to
completing this research."

TO L E A R N M O R E A B O U T P K D R E S E A R C H , V I S I T C L I N I C A L S T U D I E S . P K D C U R E .O R G

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PKD Life - Fall 2020

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