RIVER EDGE, N.J., —Nephros, Inc. announced the company has received 510(k) clearance from the Food and Drug Administration (FDA) to market its Hemodiafiltration (HDF) system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards in the United States.

The system is comprised of Nephros's OLpur MD220 Hemodiafilter and Nephros's OLpur H2H Hemodiafiltration module. Nephros's OLpur MD220 Hemodiafilter is a dialyzer designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Hemodiafiltration technology. Nephros's OLpur H2H Hemodiafiltration module is intended for use with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards.

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End stage renal disease (ESRD), often also referred to as chronic renal failure, occurs when the number of nephrons in the kidneys and the size of the kidneys have been reduced to the point that they can no longer carry out their functions.

The basic working unit of the kidneys is the nephron. In normal kidneys, there are millions of these tiny filtering units. The list of diseases that can destroy nephrons, and eventually lead to ESRD, is very long. The diseases range from inherited conditions, such as polycystic renal disease, to the many inflammatory diseases called glomerulonephritis, to the common diseases hypertension and diabetes. Thirty years ago, the group of diseases called chronic glomerulonephritis were the most common causes of ESRD, but today hypertension and diabetes have taken the lead.

What is end stage renal disease?

The loss of nephrons in all of these diseases tends to take place slowly, and the ability of the kidneys to compensate for this loss is enormous, so ESRD tends to occur late in the history of the causative disease. In the case of diabetes, it is typically a complication that shows up only after a person has had diabetes for 20 to 30 years, although testing earlier for protein in the urine may show the beginnings of the problem. Because of this ability to compensate for the loss of nephrons, the stage of renal disease called ESRD does not appear until about 75 percent of the nephrons have been destroyed. The diagnosis of ESRD will be made when the amount of urea and creatinine in the blood start rising, and a test called the glomerular filtration rate shows that the kidneys’ ability to function has been reduced by 75 percent or more. If an acute cause of the decreased function, such as infection, is not present, it is termed ESRD.

Once nephrons have been destroyed, there is no treatment that will cause new ones to develop. However there is increasing proof that controlling the underlying disease, such as diabetes, will slow or stop the loss of nephrons and thereby prevent the eventual development of this terrible complication. Since diabetes and hypertension are both controllable diseases, as are many of the other causes of ESRD, there is a great emphasis now in controlling these conditions and preventing ESRD.

Once ESRD has been diagnosed, the treatment options are limited. Because the kidneys control the amount of fluid and the acid-base balance in the body, as well as the concentrations of many components of the blood, including sodium, and the excretion of the end products of protein metabolism, such as urea and creatinine, the treatment of ESRD requires careful attention to fluid and electrolyte balance and diet.

When the loss of nephrons no longer permits these functions to be carried out sufficiently to maintain life, the person suffering from the condition must go on long-term renal dialysis, or have a kidney transplant.

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George E. Schreiner, 89, a Georgetown University medical school nephrologist who was a leading figure in the study of kidney disease and dialysis, died April 12 at Sunrise assisted living in Reston. He had Alzheimer’s disease.

The death was confirmed by his son William Schreiner.

Dr. Schreiner served on the Georgetown faculty from 1951 to 1987, when he was named a distinguished professor of medicine. He was a top clinical researcher in the technique of hemodialysis, employing an artificial kidney, and showing its effectiveness in prolonging the lives of patients with end-stage renal disease.

In the 1960s, Dr. Schreiner helped start a Georgetown fellowship program for nephrologists. In the 1970s, he was a key player in successful efforts to secure federal payments for kidney dialysis and organ transplants.

Dr. Schreiner wrote for professional journals and book chapters, and he was a past president of the American Society of Nephrology, the International Society of Nephrology, the American Society for Artificial Internal Organs, and the National Kidney Foundation. He received many professional honors.

While leading the National Kidney Foundation in the early 1970s, Dr. Schreiner helped orchestrate a national campaign to encourage adults to carry a Uniform Donor Card that allowed physicians to use the holder’s organs for transplantation or other medical purposes.

The card followed passage of the Anatomical Gift Act of 1968. “Several years ago we recognized that, as transplants become more feasible, there would be a shortage of suitable donors,” Dr. Schreiner told the New York Times in 1970. The card makes it possible for a doctor to act without having to find the next of kin.

George Elmer Schreiner was a native of Buffalo, N.Y., and he was a 1943 graduate of Canisius College there. He graduated in 1946 from Georgetown University’s medical school, followed by a fellowship at New York University’s medical center under the noted renal physiologist Homer W. Smith. He served in the Army Medical Corps during the Korean War.

Dr. Schreiner, a Great Falls resident, was a master gardener and a member of the Cosmos Club.

His wife of 58 years, Joanne Baker Schreiner, died in 2006. Their son Robert died in infancy in 1957.

Survivors include seven children, Dr. George F. Schreiner of Los Altos Hills, Calif., Mary Schreiner of Manhattan, N.Y., Dr. Meredith Maclay of Great Falls, William Schreiner of Reston, Sara Kendall of University Place, Wash., Peter Schreiner of Ojai, Calif., and Lise Salmon of Mill Valley, Calif.; a sister; 19 grandchildren; and three great-grandchildren.

— Adam Bernstein

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