National, Universal Living Donor Kidney Registry and At-Home Living Donor Testing Kit: Interview with David Fleming, President and CEO of DLA

The Fresenius Medical Care Foundation
(FMCF), which is the nonprofit arm of Fresenius Medical Care North America
(FMCNA), has teamed up with Donate Life America
(DLA), another non-profit, to create a universal living donor kidney registry
and at-home living donor testing kits.

Approximately 30 million people in the United
States are affected by kidney disease, with another person being added to the
kidney transplant waiting list every ten minutes. At present, the majority of
kidney transplants are possible because of deceased donors, but there is a
shortage of such donors leading to increased wait times for those needing a
transplant. In fact, there are approximately 95,000 people on the transplant
waiting list.

Another option involves living donors providing a kidney, and such transplants often have better outcomes than those performed with a kidney from deceased donors. The public has expressed interest in acting as living donors, but there is currently no way for them to register their interest and find a match in terms of a suitable recipient for their donated kidney.

To address these issues, this new
collaboration intends to introduce the first national living donor registry,
where those interested in acting as a donor can register their intent. In
addition, the plan involves providing potential donors with at-home test kits
so that they can test their saliva and find a potential kidney recipient match
as soon as possible. The test should streamline the process and help to reduce
waiting times for those needing a transplant.  

Medgadget had the opportunity to talk to David Fleming, President and CEO of DLA, to discuss the partnership.

Conn Hastings, Medgadget: Please give us an overview of the current issues facing those needing a kidney transplant.

David
Fleming, Donate Life America
: An estimated 30 million
Americans have kidney disease
—and that number
is expected to grow with an increasingly at-risk population.
Kidney transplantation is the best option for eligible patients living with
kidney failure. 95,000 people are currently on the kidney transplant waiting
list – and another person is added approximately every ten minutes. The need is
clear, and solutions will call for systemic collaboration and innovative
partnerships to increase the number of transplants for people living with
kidney disease.

Medgadget: Please give us an overview of the partnership between Fresenius Medical Care Foundation (FMCF) and Donate Life America (DLA). How did the partnership come about, and what benefits will it provide for patients with kidney disease and prospective living donors?

David
Fleming
: The recent Fresenius Medical
Care Foundation
(FMCF) grant to Donate Life America (DLA) is one of
the innovative partnerships that will help to increase lifesaving kidney
transplants. DLA is committed to educating the public about the need for
donation and bringing deceased and living donation registration opportunities
to more people. Without the generosity of the donor, there is no transplant.
The FMCF is focused on transplant and on improving lives by raising awareness
of kidney disease and igniting the advancement of lifesaving solutions.

As we
talked, we knew that in order to increase living donation we needed a clear,
consistent national call to action to register your interest in being a living
donor. We know there is public interest in living donation, and we need to make
it an easy, intuitive process for them to get more information.

FMCF,
the nonprofit arm of Fresenius Medical
Care North America
(FMCNA), has given $500,000 to DLA to launch
two new initiatives focused on living donation in 2020:

First,
a national, universal living donor registry that will offer the opportunity for
the public to register their interest in becoming a living donor. This new
registry will be built as part of the already existing, secure, and trusted
National Donate Life Registry that houses deceased organ, eye and tissue donor
registrations. Additionally, this platform will capture preliminary results
from the new at-home testing kits and interface with the United Network for
Organ Sharing (UNOS) to find lifesaving matches nationwide.

Additionally, DLA
and FMCF will create a living donor testing kit to enable a faster, easier
at-home screening option, vital to helping identify potential living donors for
kidney transplant.

Medgadget: How does the new at-home living donor test work? Can users get an instant result at home, or will they send a saliva sample for analysis elsewhere?

David
Fleming
: Potential living donors who express interest in donating a
kidney will be asked to complete a brief online health screening questionnaire,
collect a sample using the at-home testing kit, and return the sample by mail
for lab analysis.

Lab
analysis will then determine the potential donor’s blood type and HLA typing;
the test results and health information will be uploaded to a secure database
and attached to the potential donor’s record in the registry. Once the
potential living donor is accepted into a transplant program’s living donor
process for their intended recipient, the transplant program will conduct a
full medical evaluation and lab testing.

Medgadget: What are the advantages of living donors, compared with deceased kidney donations?

David
Fleming
: This year, an estimated 20,000 people on the kidney transplant
waiting list will receive a kidney transplant, primarily from deceased donors.
There is a shortage of deceased donor kidneys to meet the needs of those
waiting for a second chance at life. Only 1% of all deaths in the U.S. are
eligible to be organ donors. Increasing donor registrations for deceased and
living donation – and increasing the number of living kidney donors are the
best options to save more lives. Living donor kidneys demonstrate higher
post-transplant success rates than deceased donor kidneys, according to United
States Renal Data System (USRDS) data. Additionally,
waiting times can be shorter with living donation. The average waiting time for
a deceased donor kidney transplant is 3-7 years. For living donor kidney
transplants, it can be one year or less. This is critical for patients awaiting
lifesaving transplants.

Medgadget: How will the new living donor registry facilitate living donors in matching with a transplant patient?

David
Fleming
: This platform will capture preliminary results from the new
at-home testing kits, and in partnership with the United Network for Organ Sharing (UNOS) and
transplant programs across the country, will allow potential living donors and
recipients to find matches nationwide. This new National Donate Life Living
Donor Registry will be an extension of our existing National Donate Life
Registry, a secure mobile optimized deceased organ, eye and tissue donor
registry. The public will now be able to add their registered interest in being
a living donor to their individual donor record.

Medgadget: When will the registry and at-home test roll out?

David
Fleming:
We will be running pilot programs in early 2020 ahead of a
national roll-out in the Spring and five transplant programs across the U.S.
will be participating in this pilot program.

The institutions participating in the pilot program will implement the use of the testing kits by sharing them with their current living donor transplant candidates to share with their personal networks and help identify potential living donors across the U.S. The potential living donors will register through the National Donate Life Living Donor Registry. The initial test kit samples will be evaluated, results will be collected, and UNOS will use the results to identify potential matches and communicate back to the pilot transplant programs.

Link: Donate Life America homepage…