Frequent Hemodialysis Clinical Trials

• Background
• Study Description

Background

End-stage renal disease (ESRD) afflicts approximately 380,000 Americans. Most receive hemodialysis three times a week for three to five hours each. This frequency is life-sustaining and generally accepted as standard therapy, but it has no solid scientific basis. Also, while some patients live a long time on hemodialysis, mortality remains quite high-about 20 percent of ESRD patients die every year.

More frequent hemodialysis has been employed by some dialysis centers in small numbers of selected patients. The modalities have included home and in-center hemodialysis delivered four to seven times per week with standard blood and dialysate flow rates. Some centers have employed a daytime therapy of shorter duration per dialysis session than with the thrice weekly schedule. Alternatively, in the nocturnal version, lower than standard flow rates have been used, but for longer periods of time than usual-often 8 hours per night. The results of these approaches to increased frequency have been reportedly good. Reductions in blood pressure, serum phosphate levels and erythropoietin requirements have been noted. Improved patient well being has also been reported. However, these observations derive from small groups of selected patients in a few centers.

Large numbers of subjects (N = 1,000 or more) are generally required to assess the effect of any change in ESRD therapy on mortality and cardiovascular events, e.g. stroke, myocardial infarction and heart failure, all of which often complicate ESRD. Based on previous studies of small numbers of daily dialysis patients, and the uncertain ability to randomize patients into daily versus conventional frequency, the trials conducted under this RFA will focus on intermediate outcomes. These outcomes include blood pressure, LVH, nutritional status, anemia quality of life, and vascular access.

Frequent Hemodialysis versus Standard Dialysis

Looking for ways to improve dialysis outcomes, NIDDK has funded four centers to test whether it is feasible to randomize a representative sample of patients into either (a) conventional thrice-weekly dialysis treatments, or (b) one of two forms of frequent dialysis. One trial will compare short daily hemodialysis with conventional dialysis and the other will compare long nocturnal dialysis with conventional dialysis. The trials will also provide preliminary data on the impact of these modalities on patients. Patients will be followed for at least six months, and intermediate outcomes related to anemia, nutritional status, blood pressure, left ventricular hypertrophy, exercise tolerance, medication use, and hospitalizations will be tracked. The results of these trials will determine whether NIDDK should continue this research with a large-scale trial powered to measure the impact of more frequent dialysis on hard endpoints such as mortality and/or cardiovascular outcomes.

The following Coordinating Clinical Centers will begin recruiting patients in Fall 2004:

• The Renal Research Institute in New York City, led by Dr. Nathan W. Levin.
• The University of California, San Francisco, led by Dr. Glenn Chertow.
• Wake Forest University, led by Dr. Michael Rocco.

The Data and Analysis Coordinating Center is at the Cleveland Clinic Foundation, led by Dr. Gerald Beck.

Studies will be completed in Fall 2008.

Program Officers: Paul Eggers, Ph.D., and Thomas Hostetter, M.D., 301-594-7717