Chronic Kidney Disease Clinical Trial
Official title:
Impact of HemoDiaFIltration on Physical Activity and Self-reported Outcomes: a Randomized Controlled Trial (HD-FIT Trial)
This is a randomized controlled clinical trial that will analyze the impact of high volume online HDF in comparison to high-flux HD on measured physical activity.
HD-FIT is a randomized controlled clinical trial that will analyze the impact of high volume
online HDF in comparison to high-flux HD on measured physical activity (number of steps
measured in the dialysis day) as a primary endpoint. The analysis of additional accelerometer
data, HRQOL and time to recover from a dialysis session will be used as other outcomes. The
study will also capture safety data, based on intradialytic events, hospitalization and
mortality. Biochemical (according to the local requirements) and drug prescription data will
be monitored for pharma-economic analysis. Serum samples will be collected for future
analysis of additional biomarkers.
In summary, patients will go through a 4 week run in period on high flux HD. After this,
patients will be randomized to the intervention of high volume online HDF for 6 months, or
will continue on high flux HD; both groups will be observed for a 12 month follow up period.
Patients will be evaluated for physical activity, HRQOL, laboratories and other measures at
the baseline, 3 month, and 6 month time points. Evaluation will be repeated in 3 and
6-months. HRQOL, laboratories, and other outcomes will be tracked over the
post-interventional follow up period that lasts 12 months after randomization.
Data will be analyzed according to an intention-to-treat principle (i.e., according to
assigned instead of received treatment). With an enrollment target of 110 participants in
each arm (considering a drop out of 20%) we estimate the 86 patients will complete the follow
up in each arm, what will provide the trial a 90% power to detect a 20% effect with respect
to the primary outcome (predefined as a 20% increase in average total steps at the dialysis
day in the HDF group compared to the HD group). Because of the nature of the intervention, it
will not possible to blind the patients, the local study nurses, or the investigators for the
treatment assignment.
Fourteen dialysis centers will be invited to participate. Each participating center will
receive two 5008S machines and Cordiax dialyzers to be used in the study of 10 patients in
each center. Additional patients can be randomized per center with approval of the steering
committee. Centralized randomization will based on a 1:1 protocol, stratified by
participating center.
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