The annual mortality rate for maintenance hemodialysis patients in the United States remains unacceptably high at 15–20%. In 2004, we initiated the Frequent Hemodialysis Network (FHN) clinical trials. This report presents baseline characteristics of FHN trial participants and compares them to hemodialysis patients tracked in USRDS data.
Two separate randomized clinical trials
Settings and participants
FHN includes 332 patients with chronic kidney disease requiring chronic dialysis therapy enrolled in two separate randomized clinical trials. The FHN Daily Trial (245 randomized subjects) was designed to compare outcomes of six times per week in-center daily hemodialysis (1.5 to 2.75 hours/session) with conventional three times per week in-center hemodialysis. The FHN Nocturnal Trial (87 randomized subjects) was designed to compare outcomes of six times per week nocturnal (6 to 8 hours/session) with conventional three times per week hemodialysis. USRDS data includes 338109 incident and prevalent chronic hemodialysis patients from the calendar year 2007.
Subjects in both trials were, on average, younger than the average hemodialysis patient in the United States (50.4 years; p<0.001 for Daily and 52.8 years; p<0.001 for Nocturnal). Compared to USRDS data, whites were underrepresented in the Daily Trial (36% versus 55%, p<0.001) while Hispanics were underrepresented in the Nocturnal Trial and overrepresented in the Daily Trial (0% versus 28%; p<0.001). In addition, there were more fistulas and fewer catheters in the Daily Trial (61% and 20% respectively, p<0.001 for both) and fewer grafts and more catheters in the Nocturnal Trial (10% and 44% respectively, p<0.005 for both).
Clinical trial exclusion criteria and patient willingness to participate limit comparisons with the USRDS.
FHN participants are younger and the racial composition for each study was different than the racial composition of the aggregate US dialysis population. Catheters for vascular access were more common in FHN Nocturnal participants.