Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
-
United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, NIH, NIDDK, Bethesda, MD, 2006
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Home Short Daily Hemodialysis Intervention: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. |
Device: NxStage System One
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
|
| Experimental: Home Nocturnal Hemodialysis Intervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. |
Device: NxStage System One
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Satellite Healthcare/Wellbound | San Jose | California | United States | 95128 |
| 2 | Circle Medical Management | Chicago | Illinois | United States | 60607 |
| 3 | Indiana University Dialysis Center | Indianapolis | Indiana | United States | 46202 |
| 4 | Kansas Nephrology Research Institute, LLC | Wichita | Kansas | United States | 67214 |
| 5 | Barnes Jewish Dialysis Center | St. Louis | Missouri | United States | 63110 |
| 6 | Dialysis Center of Lincoln | Lincoln | Nebraska | United States | 68512 |
| 7 | Rubin Dialysis | Saratoga Springs | New York | United States | 12866 |
| 8 | DaVita Grapevine at Home | Grapevine | Texas | United States | 76051 |
| 9 | DaVita Bluemound Home Dialysis | Wauwatosa | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- NxStage Medical
Investigators
- Study Director: Paul Kravitz, NxStage Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP0010
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis |
|---|---|
| Arm/Group Description | 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. In this prospective, two treatment, cross-over study, 58 End Stage Renal Disease patients >18 years of age who were currently stable on home DHD were enrolled. Enrolled patients performed Intervention 1 as the first phase of the cross-over study. Fifty-one patients completed Intervention 1 and seven patients dropped out. Forty-three patients completed the training/transition period and performed Intervention 2 as the second phase of the cross-over study. Thirty-nine patients completed Intervention 2 and four patients dropped out. |
| Period Title: Intervention 1: Home DHD | |
| STARTED | 58 |
| COMPLETED | 51 |
| NOT COMPLETED | 7 |
| Period Title: Intervention 1: Home DHD | |
| STARTED | 51 |
| COMPLETED | 43 |
| NOT COMPLETED | 8 |
| Period Title: Intervention 1: Home DHD | |
| STARTED | 43 |
| COMPLETED | 39 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis |
|---|---|
| Arm/Group Description | 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. |
| Overall Participants | 58 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
53
(13)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
20
34.5%
|
| Male |
38
65.5%
|
Outcome Measures
| Title | Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all electronically captured treatments. |
| Arm/Group Title | Home Short Daily Hemodialysis | Home Nocturnal Hemodialysis |
|---|---|---|
| Arm/Group Description | Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. | Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. |
| Measure Participants | 58 | 43 |
| Measure Treatments | 1866 | 1431 |
| Number (95% Confidence Interval) [percentage of successful treatments] |
90.9
|
91.7
|
| Title | Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. |
|---|---|
| Description | The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile. |
| Time Frame | Study Week 20 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Includes all patient reported treatments. |
| Arm/Group Title | Home Short Daily Hemodialysis | Home Nocturnal Hemodialysis |
|---|---|---|
| Arm/Group Description | Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. | Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. |
| Measure Participants | 58 | 43 |
| Measure Treatments | 2373 | 1792 |
| Number [events per 100 treatments] |
8.3
|
6.9
|
Adverse Events
| Time Frame | Adverse events were reported during the 20 week period of study participation. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Home Short Daily Hemodialysis | Nocturnal Home Hemodialysis | ||
| Arm/Group Description | Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. | Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. | ||
All Cause Mortality |
||||
| Home Short Daily Hemodialysis | Nocturnal Home Hemodialysis | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Home Short Daily Hemodialysis | Nocturnal Home Hemodialysis | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/58 (22.4%) | 5/43 (11.6%) | ||
| Cardiac disorders | ||||
| Angina/Chest Pain | 2/58 (3.4%) | 2 | 0/43 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Colitis | 0/58 (0%) | 0 | 1/43 (2.3%) | 1 |
| General disorders | ||||
| Infection | 2/58 (3.4%) | 2 | 2/43 (4.7%) | 2 |
| Abdominal Pain | 1/58 (1.7%) | 2 | 0/43 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal Injuries | 6/58 (10.3%) | 6 | 0/43 (0%) | 0 |
| Renal and urinary disorders | ||||
| Hypertension | 1/58 (1.7%) | 1 | 0/43 (0%) | 0 |
| Surgical and medical procedures | ||||
| Eye surgery | 0/58 (0%) | 0 | 1/43 (2.3%) | 1 |
| Vascular disorders | ||||
| Vascular Access Issues | 4/58 (6.9%) | 6 | 1/43 (2.3%) | 2 |
| Cerebrovascular Accident | 1/58 (1.7%) | 1 | 0/43 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Home Short Daily Hemodialysis | Nocturnal Home Hemodialysis | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 40/58 (69%) | 30/43 (69.8%) | ||
| Gastrointestinal disorders | ||||
| Diarrhea | 0/58 (0%) | 0 | 5/43 (11.6%) | 8 |
| General disorders | ||||
| Cold/Flu-like Symptoms | 12/58 (20.7%) | 17 | 6/43 (14%) | 8 |
| Other | 9/58 (15.5%) | 26 | 4/43 (9.3%) | 20 |
| Clotted Dialysis Blood Lines | 0/58 (0%) | 0 | 3/43 (7%) | 3 |
| Fatigue | 3/58 (5.2%) | 4 | 4/43 (9.3%) | 5 |
| General Bodily Pain | 2/58 (3.4%) | 4 | 3/43 (7%) | 4 |
| Renal and urinary disorders | ||||
| Hypotension/Hypovolemia/Cramping | 22/58 (37.9%) | 71 | 13/43 (30.2%) | 26 |
| Dialysis-related blood loss | 5/58 (8.6%) | 6 | 3/43 (7%) | 5 |
| Vascular disorders | ||||
| Vascular Access Problems | 12/58 (20.7%) | 20 | 8/43 (18.6%) | 16 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Kristen Sheppard |
|---|---|
| Organization | NxStage Medical, Inc. |
| Phone | 978-687-4700 |
- CP0010