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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Short Daily Hemodialysis | Active Comparator | Intervention: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. |
|
| Home Nocturnal Hemodialysis | Experimental | Intervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NxStage System One | Device | Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Study Week 20 |
| 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. | Study Week 20 |
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Inclusion Criteria:
Exclusion Criteria:
Patients are not eligible if:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Kravitz | NxStage Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satellite Healthcare/Wellbound | San Jose | California | 95128 | United States | ||
| Circle Medical Management |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41071621 | Derived | Liu F, Abra G, Gupta N, Schiller B, Rivara MB. How I Treat Nocturnal Home Hemodialysis-An Underprescribed but Essential Home Dialysis Modality in the United States. Clin J Am Soc Nephrol. 2025 Oct 10;21(5):907-9. doi: 10.2215/CJN.0000000927. Online ahead of print. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention 1: Home DHD |
|
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| Chicago |
| Illinois |
| 60607 |
| United States |
| Indiana University Dialysis Center | Indianapolis | Indiana | 46202 | United States |
| Kansas Nephrology Research Institute, LLC | Wichita | Kansas | 67214 | United States |
| Barnes Jewish Dialysis Center | St Louis | Missouri | 63110 | United States |
| Dialysis Center of Lincoln | Lincoln | Nebraska | 68512 | United States |
| Rubin Dialysis | Saratoga Springs | New York | 12866 | United States |
| DaVita Grapevine at Home | Grapevine | Texas | 76051 | United States |
| DaVita Bluemound Home Dialysis | Wauwatosa | Wisconsin | 53226 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| Training/Transition Period |
|
| Intervention 2: Home NHD |
|
58 patients were enrolled in the cross-over study. Patients were required to complete the home short daily hemodialysis phase before transitioning to the home nocturnal hemodialysis phase.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Includes all electronically captured treatments. | Posted | Number | 95% Confidence Interval | percentage of successful treatments | Study Week 20 | Treatments | Participants |
|
|
| ||||||||||||||||||||||||||||
| 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. | Includes all patient reported treatments. | Posted | Number | events per 100 treatments | Study Week 20 | Treatments | Participants |
|
|
Adverse events were reported during the 20 week period of study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home Short Daily Hemodialysis | Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. | 13 | 58 | 40 | 58 | ||
| EG001 | Nocturnal Home Hemodialysis | Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. | 5 | 43 | 30 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina/Chest Pain | Cardiac disorders | Non-systematic Assessment |
| ||
| Musculoskeletal Injuries | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Non-dialysis related joint sprains, tears, and fractures |
| |
| Hypertension | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Vascular Access Issues | Vascular disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | General disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Vascular disorders | Non-systematic Assessment |
| ||
| Eye surgery | Surgical and medical procedures | Non-systematic Assessment | non-dialysis related |
| |
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold/Flu-like Symptoms | General disorders | Non-systematic Assessment |
| ||
| Other | General disorders | Non-systematic Assessment | other singular non-dialysis-related events |
| |
| Clotted Dialysis Blood Lines | General disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vascular Access Problems | Vascular disorders | Non-systematic Assessment | i.e. poor access flow, painful access, bleeding |
| |
| Hypotension/Hypovolemia/Cramping | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Dialysis-related blood loss | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| General Bodily Pain | General disorders | Non-systematic Assessment | i.e. shoulder pain, back pain |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Sheppard | NxStage Medical, Inc. | 978-687-4700 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Treatments |
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