WINSTON-SALEM, N.C. – Recruiting has begun for a national research study of patients with chronic kidney disease to test whether six-times-a-week home dialysis over-night works as well or better than three-times-a-week dialysis, also done at home. The study is one of two dialysis studies getting under way at Wake Forest University Baptist Medical Center.
The national study involves hemodialysis, in which the blood is cleaned by a kidney-dialysis machine. It is also known as chronic dialysis therapy because the patient’s kidneys have permanently failed, requiring dialysis for the rest of their lives.
Michael V. Rocco, M.D., the national principal investigator, said that about 250 patients would be recruited in the United States and Canada – including at least 12 at Wake Forest Baptist.
Rocco said patients will be trained to perform their hemodialysis sessions at home. The six-times-a-week dialysis would be done overnight, lasting at least six hours per night, while the three-times-a-week dialysis would be with the more standard three-to-four hour sessions during the day or evening. Each patient will be in the study for 12 months.
The study is paid for by a $3.3 million grant from the National Institutes of Health (NIH) and the Centers for Medicare and Medicaid Services (CMS) and was developed and organized by the Frequent Hemodialysis Network, a group of investigators selected by NIH for their expertise in dialysis care.
Rocco, professor of internal medicine-nephrology, said it is the first time that the NIH has paid for a study involving dialysis other than the standard three times per week.
“Is more dialysis better?” is the key question of the study. “Dialysis provided for 36 or more hours per week will result in the removal of much more toxins than standard dialysis, which provides for only 9 to 12 hours of dialysis per week,” Rocco said. The study will help determine if removal of more toxins is beneficial to patients on dialysis.
The researchers will determine whether this higher dose of dialysis will reduce heart enlargement, improve quality of life, lower blood pressure, and improve physical activity, mental functioning and blood chemistry values.
The other clinical centers recruiting patients in the United States are Lynchburg Nephrology in Lynchburg, Va., Rubin Dialysis Center in Saratoga Springs, N.Y, Washington University in St. Louis, Mo.; and the University of Iowa in Iowa City, Iowa. The Canadian centers in the study are Humber River Regional Hospital in Weston, Ontario, the University of Toronto in Toronto, Ontario, the University of Western Ontario in London, Ontario, the University of Calgary in Calgary, Alberta, and the University of British Columbia in Vancouver, British Columbia.
The second study will compare two different hemodialysis therapies at outpatient hemodialysis centers. Half the patients will get the standard three-times-a-week dialysis for three to four hours, while the other half will go to the dialysis center six days a week, but for a shorter period of time of between 1.5 and 2.75 hours.
The patients in the study, also supported by NIH and CMS, will likely come from the hundreds of patients who get dialysis at the 13 dialysis centers owned by Wake Forest University Health Sciences in Forsyth, Guilford, Davidson, Iredell, Stokes and Surry counties.
This six-times-per-week hemodialysis will remove more toxins than the standard three- times-per-week therapy, but less than the amount of toxins removed by home hemodialysis done six nights per week. The study will measure the same patient outcomes as those in the national study.
The recruiting goal for the second study is at least 24 patients, Rocco said.
Tina Kaufman is the recruiter for both studies. She can be reached at the Piedmont Dialysis Center at (336) 721-1360, extension 110, or at email@example.com.
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Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.