The FHN Nocturnal Core Clinical Consoritum is comprised of clinical centers in the United States, Canada and Australia and is responsible for conducting a randomized, two-arm, unblinded clinical trial of standard hemodialysis (SHD, 3 days per week) versus nocturnal home hemodialysis (NHD, 6 times per week). The two co-primary outcomes are the change from baseline to 12 months of follow-up in left ventricular mass, as measured by cardiac MRI, and in the SF-36 RAND physical health composite. Due to difficulties with patient recruitment, the protocol was changed so that patients in the standard arm received HD at home instead of in-center. It was felt that patients interested in NHD would be more receptive to enrolling in the study if both arms of the study were home based therapies. The new one year Vanguard phase of this revised protocol runs from 2/2/07 to 2/1/08, followed by an additional 26 months of recruitment (to 4/02/10), 12 months of follow-up (to 4/1/11) and 3 months for study closeout (to 6/30/11). In September 2007. the results of a small randomized trial conducted were published which showed a significant reduction in LV mass, but no improvement in quality of life, in patients who received NHD. Based of these study results and the lower than expected recruitment rate in the Nocturnal Study, the DSMB approved a decrease in the sample size for this trial from 250 patients to 150 patients. The consoritum is currently randomizing about 3 patients per month into the Nocturnal Study and has randomized 38 patients as of 10/25/07. With the addition of an Australian site in early 2008 and reallocation of funding resources to well-performing sites, we should be able to randomize 150 patients into the trial prior to March 2010. Excellent separation in the dose of dialysis and the time spent per week receiving dialysis has been achieved between the two arms of the study. The mean weekly standard Kt/V is 4.70 in for NHD and 2.21 for SHD. The mean time on dialysis per week is 34.0 hours for NHD and 12.1 hours for SHD. The compliance with the dialysis prescription has been greater than 95% for SHD and greater than 90% for NHD. The forms completion rate has been 84% for F4 forms, 88% for F8 forms and 78% for F12 forms. The SAE event rate with 24.5 years of follow-up is is 0.65 events per patient year, of which hospitalizations account for 87.5% of SAEs, life-threatening events account for 6.3% of SAEs and deaths account for 6.3% of SAEs.
