N/A
N=58
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
Kidney Failure, Chronic · End-Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00667511 ↗Enrolled (actual)
58
Serious AEs
17.8%
Results posted
Jan 2015
Primary outcome: Primary: Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. — 90.9; 91.7 percentage of successful treatments
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NxStage System One (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NxStage Medical
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. |
90.9; 91.7 | — |
| PRIMARY Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. |
8.3; 6.9 | — |
Summary
The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the NxStage System One in the home setting.
Eligibility Criteria
Inclusion Criteria
- Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.
Exclusion Criteria
- Patients are not eligible if:
- they are currently enrolled in another drug or device study which could impact the successful completion of this study
- they are currently on NHD, or less than 3 months since discontinuing NHD
- if they were previously enrolled in this study.
Data sourced from ClinicalTrials.gov (NCT00667511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.