Frequent Hemodialysis Clinical Trials
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
Last Update: 2/17/2004
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