End-Stage Renal Disease, Kidney Failure, Chronic
Conditions
Keywords
ESRD, End Stage Renal Disease, Daily Hemodialysis, Nocturnal Hemodialysis, Hemodialysis, Kidney Failure, Kidney Disease
Brief 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.
Detailed description
End Stage Renal Disease (ESRD) continues to be a devastating clinical condition. The number of patients in 2004 affected by ESRD in the United States rose to 472,000. More than 104,000 new patients began therapy for ESRD in 2004 (1.5% greater than in 2003), while the prevalent dialysis population reached nearly 336,000 (3.4% higher). Total Medicare costs for ESRD in 2004 rose to $20.1 billion while non-Medicare costs rose to $12.4 Billion(1). Treatment options for ESRD patients are currently limited to either transplantation or dialysis. As daily hemodialysis (DHD) continues to gain widespread acceptance in the dialysis community, there is also renewed interest in nocturnal hemodialysis (NHD) therapy. NHD has the potential to provide certain advantages over both DHD and conventional thrice-weekly in-center HD. NHD typically consists of 6 - 10 hour treatments while the patient sleeps, providing more gentle fluid removal, more time for equilibration, improved hemodynamic stability and superior clearance of larger solutes(2). The proposed study plans to explore whether or not NHD is equivalent to DHD on a per treatment basis, using the NxStage System One in the home setting. 1. United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, NIH, NIDDK, Bethesda, MD, 2006 2. Lacson E, Diaz-Buxo J: Daily and Nocturnal Hemodialysis: How do they stack up? American Journal Kidney Disease, Vol 38(2) Aug 2001: 225-239.
Interventions
DEVICENxStage System One
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
Sponsors
NxStage Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. | Study Week 20 | The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval). |
| Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. | Study Week 20 | The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis Intervention 1: Patients performed short daily hemodialysis (DHD) (2 to 4 hour treatments) in the home setting using the NxStage System One for an 8 week period.
Intervention 2: Patients completing Intervention 1 and successfully completing a 4 week training/transition period proceeded to perform nocturnal hemodialysis (NHD) (6 to 10 hour treatments) in the home setting using the NxStage System One for an 8 week period. | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 40 / 58 | 30 / 43 |
| serious Total, serious adverse events | 13 / 58 | 5 / 43 |
Outcome results
Primary
Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
The primary efficacy endpoint for the study was the ability to deliver the clinically prescribed amount of therapy, defined by attainment of a delivered volume that was at least 90% of the prescribed volume (10% difference in success rate is the upper boundary of the 95% confidence interval).
Time frame: Study Week 20
Population: Includes all electronically captured treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Short Daily Hemodialysis | Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. | 90.9 percentage of successful treatments |
| Home Nocturnal Hemodialysis | Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. | 91.7 percentage of successful treatments |
Primary
Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
Time frame: Study Week 20
Population: Includes all patient reported treatments.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Home Short Daily Hemodialysis | Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. | 8.3 events per 100 treatments |
| Home Nocturnal Hemodialysis | Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. | 6.9 events per 100 treatments |