Frequent Hemodialysis Network: Nocturnal Study

Prior observational studies have shown multiple benefits of both frequent hemodialysis (HD) and frequent nocturnal HD compared to conventional three times per week treatments for patients with end-stage renal disease (ESRD). To test these hypotheses, the Frequent Hemodialysis Network (FHN) Trials Group conducted two multicenter randomized trials to compare conventional tree times weekly HD with (1) in-center daily and (2) home nocturnal HD. Specifically, the FHN Nocturnal trial was designed to assess the effects of frequent nocturnal home HD six times per week compared with conventional three times per week HD.

Participants with ESRD requiring maintenance dialysis were recruited from 19 clinical centers. A total of 87 subjects were enrolled, underwent baseline assessment, and were randomized to treatment, either to three times per week conventional HD or to nocturnal HD six times per week, all with single-use high-flux dialyzers. Participants were followed for 14 months. The composite of mortality with change in (1) left ventricular mass index (LVMI) by magnetic resonance imaging (MRI), and (2) SF-36 RAND Physical Health Composite (PHC) were used as co-primary outcomes to assess the efficacy of treatment. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions.

The FHN Nocturnal trial found no significant effect of nocturnal hemodialysis for either of the two co-primary outcomes. Results showed that patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but there was no significant benefit to frequent nocturnal hemodialysis among the other main secondary outcomes. While the nocturnal study was unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either co-primary outcome, these results differ from the FHN Daily Trial, which showed a statistically significant benefit of more frequent hemodialysis for both co-primary outcomes.
The primary objective of the FHN Nocturnal trial was to compare the effects of conventional (three times per week) and frequent (six times per week) hemodialysis treatment for patients with ESRD, specifically to assess the safety, efficacy, and cost-effectiveness of the two treatments.