Need

  • End stage renal disease (ESRD) is fatal unless treated.
  • Transplantation is the best option, but donor organs are in short supply.
  • Dialysis is a short-term and costly treatment.
  • The population of ESRD is increasing at a rate of 5% per year.
  • 1% of the Medicare population suffers from ESRD, yet treatment costs make up 6% of the Medicare budget.

The Kidney Project aims to change the status quo.

End stage renal disease

Chronic kidney disease (CKD) is the slow, progressive loss of kidney function over time. The last stage of CKD, known as end stage renal disease (ESRD), is a near-complete-to-total kidney failure. As a result, the kidneys cannot perform their normal, life-essential roles of:

  • Removing naturally occurring, but toxic, byproducts of metabolism from the blood.
  • Removing excess water and salts from the blood to maintain blood pressure.
  • Replenishing proper amounts of chemicals in the blood such as sodium, phosphorus, and potassium to maintain acid-base and electrolyte balance.
  • Producing hormones.

Because of the critical and varied roles the kidneys play, many patients whose kidneys fail become extremely ill and suffer high cardiovascular and infectious mortality. Without treatment, ESRD patients will die.

The only options to extend the lives of ESRD patients are the short-term solution of dialysis or the longer-term solution of kidney transplantation. While transplantation remains the best current treatment, a severe shortage of donor organs leaves this option out of reach for many ESRD patients. Both treatments have serious risks and challenges.

ESRD takes a huge, personal toll on patients and their families and a financial toll on the nation’s health care system. Sadly, the population of ESRD, both nationally and internationally, is increasing, especially in populations with existing chronic illnesses such as diabetes and hypertension.

Need for a new treatment option

There is a pressing need for an effective, patient-friendly, permanent, and cost-effective way to treat ESRD—a treatment that gives patients the functional benefits of a live kidney in the face of an inadequate supply of donor organs while saving health care dollars. How can this need be met?

Dialysis was first used to treat a patient with ESRD in 1943; the first kidney transplant was performed in 1962. Since then, there have been advances in both dialysis technology and transplant surgery, as well as in the development of immunosuppressant drugs, but little progress has been made in alternative treatment options. As of today, there are only two treatment options; we are in the process of adding a third.

Why now?

Before a new ESRD treatment option could be created, dramatic advances had to be made in the science and technologies required to perform many of the metabolic, endocrine, and immunological functions of a healthy kidney.

These scientific challenges are now met.

  • Silicon nanotechnology makes it possible to mass-produce reliable, robust, and compact membranes.
  • Novel molecular coatings for silicon make it blood-compatible and protect membranes without disrupting functionality.
  • Advances in cell sourcing and storage capabilities provide necessary cells at the proper conditions.

A national team of scientists, engineers, and clinicians is taking full advantage of these developments by pushing forward toward a new treatment option for ESRD. The nation needs effective and affordable health care now more than ever; it is the time for this work to succeed.

The Kidney Project

The Kidney Project national research team is being led by Shuvo Roy, PhD, a bioengineer and faculty member in the Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California, San Francisco (UCSF).

The team is developing a surgically implanted, free-standing bioartificial kidney to perform the vast majority of the filtration, balancing, and other biological functions of the natural kidney. The two-part device leverages recent developments in silicon nanotechnology, membrane filtration, and cell science. It is powered by the body’s own blood pressure without the need for external tubes and tethers or immunosuppressant drugs.

UCSF is the appropriate home base for the project. It’s known worldwide as an institution that attacks biomedical problems with the kind of interdisciplinary zeal required to carry forward an effort this bold. And UCSF has made The Kidney Project a campus research priority.

The need for a new ESRD treatment option is great and growing, and the timeline therefore is ambitious. The Kidney Project team anticipates first-in-human clinical trials in 2017.

More about the need

  • Statistics on the incidence, treatment options, and costs of end stage renal disease
  • Chronology of end stage renal disease treatment development from 1902 to present
  • A call for support from Dr. Shuvo Roy