Kidney Health Initiative Roadmap for Kidney Replacement Therapy

• Renal Replacement Therapy
• Acute Kidney Injury

The conception of the Technology Roadmap for Innovative Approaches to KRT occurred during the 2016 White House Organ Summit, which called for an increase in medical breakthroughs and innovative developments. This event prompted the Kidney Health Initiative (KHI) to leap into action and create a steering committee to bring a roadmap for the future of KRT to fruition. One of the most respected concepts of the KRT Technology Roadmap was its insistence on bringing to the table people with kidney disease and those that are caregivers/partners.

The Steering Committee and workgroups, in consultation with people with kidney disease and care partners, collectively and collaboratively designed the KRT Technology Roadmap with several goals.

1. To acknowledge that too many at-risk patients progress to late-stage kidney failure, the mortality rate is too high, current treatment options are expensive and do not produce an acceptable quality of life, and there are not enough kidneys donated to meet the current demand for transplant.

2. To increase patient choice through affordable alternative treatments for kidney failure by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of an artificial kidney (implantable and/or wearable).

3. To produce a strategy for encouraging the commercialization of innovative new therapies through the Kidney Innovation Accelerator (KidneyX). KHI, a public–private partnership between the Department of Human Health Services and the American Society of Nephrology. KHI aims to catalyze innovation and the development of safe and effective patient-centered therapies for people living with kidney disease.

The Roadmap focused on accelerating innovation and outlines strategies/pathways intended to foster the development of patient-centered, commercially viable advances in KRT. Innovative therapies and solutions covered in the Roadmap are listed below in order of when they may become available to patients.

1. Enhanced dialysis: incremental improvements to existing dialysis. This would benefit the patient by increasing treatment flexibility and reducing disease complications.

2. Portable/wearable: external devices that provide alternatives to stationary treatments. This would offer patients increased flexibility, independence, and freedom of movement; continuous or semicontinuous treatment; and it could reduce the effects of the treatment and side effects normally experienced during dialysis.

3. Implantable/biohybrid: bioengineered products that can mimic kidney function. This would benefit patients with continuous treatments and reduce treatment impact (e.g., improve thirst, dietary restrictions, work, exercise, and mobility).

4. Regenerated kidney: recovered and maintained kidney function. This would reduce the effect of kidney disease on a patient’s quality of life, health, and wellness.

The Steering Committee and workgroups did their due diligence in acknowledging that the patient’s perspective was the driving force behind the strategy, design, structure, and implementation of innovative therapies. The strength of the members of the Steering Committee and workgroups is that they knew that there is no “one size fits all” strategy for KRT. The diversity of the members addressed health equity issues such as race, ethnicity, socioeconomic status, and education, which can have an overall effect on the access to quality of care and treatment. They functioned with the understanding that those affected by kidney disease differ in engagement with their therapy, health literacy, risk tolerance to novel therapies, site of care (in-center versus home), and access to technology.To fully understand the effect of the Roadmap on today’s kidney community, we must journey back in history for a moment. In 1960, Dr. Belding Scribner and his colleagues at the University of Washington developed the Scribner shunt, a device made of Teflon. This device could link an artery and a vein and became an incredible medical technological innovation for the possibility of long-term dialysis use.

The following is a chronological list of influential changes that have occurred in the kidney community since the development of the Scribner shunt:

1. 1964: the Mini Monster, the first home hemodialysis machine, was developed. The machine was 22-foot long.

2. Late 1960s: peritoneal dialysis was developed and supervised by Henry Tenckhoff and Norman Lasker.

3. 1972: President Richard M. Nixon authorized the Medicare Kidney Disease Entitlement: The Social Security Amendments of 1972, which authorized coverage of payments of kidney dialysis and related treatments.

On July 10, 2019, President Trump signed the Advancing American Kidney Health Initiative Executive Order. It was an honor to be among a sea of patients, clinicians, researchers, innovators, and other stakeholders to witness the signing. One of the driving forces behind this initiative was the development and implementation of the KRT Technology Roadmap. Before the Executive Order and KRT Roadmap, very little was done in the development of next-generation KRT devices that are specific to improving the quality of life that patients so desperately seek while trying to find and maintain the balance of living with CKD. The key points from the Advancing American Kidney Health are as follows:

1. Prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventative care;

2. Increase patient choice through affordable alternative treatments for ESKD by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys; and

3. Increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations.

My experience on dialysis leads me to agree with the authors of the recent article on the Roadmap published in CJASN that “Although innovation in many areas of science has been transformative, there has been little innovation in dialysis or alternatives for KRT since its introduction approximately 70 years ago” (1).

On August 19, 2019, I was very fortunate to participate in the Innovations in Dialysis—Expediting Advances Symposium (IDEAS) Conference in Seattle, as a Patient Panelist. The IDEAS Conference brought together innovators of wearable, portable, and implantable dialysis technologies, including researchers, entrepreneurs, physicians, patients, industry representatives, and government officials committed to improving the outcomes and reducing cost for people with ESKD. The goal is to transform dialysis. I am a former peritoneal and hemodialysis patient of 4 years and I have been transplanted with my new kidney since April 21, 2017. As part of the IDEAS Conference experience, attendees were invited to a reception at the Dialysis Museum at the Northwestern Kidney Centers. After listening and reading the history of dialysis and viewing all the machines from conception to now, the first thing that I thought about was the Roadmap.

As I stood in front of the History of Dialysis display at the museum, I began to reflect on my kidney journey. Dialysis was a needed, yet burdensome process for me. The performing five exchanges per day, 7 days a week, for 4 years. I have logged >14,115 hours of dialysis, which does not include the 24 hours of dialysis per day that I had to perform for 33 days after receiving my kidney transplant, because of delayed graft function. Between those treatments were an additional three surgeries (blood clot in my neck, internal bleeding, and laparoscopic peritoneal window for internal drainage). My kidney did not begin to function properly until the 47th day. Because of the courageous men and women who developed the KRT Technology Roadmap, all the innovators that will design new products, and the industry that will commercialize new products, I can rest assured that my children, my grandchildren, and the next generation of at-risk people can look forward to medically innovative technology that can address their needs when it comes to kidney disease and its comorbidities, such as diabetes, hypertension, cardiovascular disease, obesity, and genetic predispositions. In over 50 years of dealing with kidney disease in the United States, it is in this very day that the hope and dream of one day finding a solution for kidney disease is within reach.

Now, I cannot wait to see what the next revision of the Roadmap looks like, if it is not in the works already. Hopefully you will be encouraged to take this prompt and apply the Roadmap and deliver innovations to all kidney patients. I can’t wait!

• Copyright © 2020 by the American Society of Nephrology