Kidney Failure, ChronicNCT00667511
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
A study testing NxStage System One in people with Kidney Failure, Chronic and End-Stage Renal Disease, run by NxStage Medical at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, End-Stage Renal Disease
- What is being tested?
- NxStage System One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2008to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Circle Medical Management
Chicago, Illinois, 60607
DaVita Grapevine at Home
Grapevine, Texas, 76051
Indiana University Dialysis Center
Indianapolis, Indiana, 46202
Dialysis Center of Lincoln
Lincoln, Nebraska, 68512
Satellite Healthcare/Wellbound
San Jose, California, 95128
Rubin Dialysis
Saratoga Springs, New York, 12866
Barnes Jewish Dialysis Center
St Louis, Missouri, 63110
DaVita Bluemound Home Dialysis
Wauwatosa, Wisconsin, 53226
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214
About this study
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.
Read the 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.
- Conditions
- Kidney Failure, Chronic, End-Stage Renal Disease
- Being tested
- NxStage System One
- Keywords
- ESRD, End Stage Renal Disease, Daily Hemodialysis, Nocturnal Hemodialysis, Hemodialysis, Kidney Failure, Kidney Disease
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NxStage System OneDevice
Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: 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. Receives: Device: NxStage System One |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Study Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- NxStage Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Kravitz, Study director, NxStage Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667511
- Sponsor's protocol ID
- CP0010
- Status last verified
- Jan 2015
- First submitted
- 24 Apr 2008
- Last updated
- 14 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 41071621
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
- ClinicalTrials.gov ID
- NCT00667511
- Acronym / sponsor ID
- CP0010
- Conditions
- Kidney Failure, Chronic, End-Stage Renal Disease
- Keywords
- ESRD, End Stage Renal Disease, Daily Hemodialysis, Nocturnal Hemodialysis, Hemodialysis, Kidney Failure, Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- NxStage MedicalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 14 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Short Daily Hemodialysis | Active comparator | Device: NxStage System OneIntervention: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One. |
| Home Nocturnal Hemodialysis | Experimental | Device: NxStage System OneIntervention: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.
Key exclusion criteria (4 listed)
- Patients are not eligible if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NxStage System OneComparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One | Device | Home Nocturnal Hemodialysis, Home Short Daily Hemodialysis |
Primary outcome
Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
Time frame: 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.
Time frame: Study Week 20
The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41071621Liu 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.
Related trials for Kidney Failure, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Kravitz study director
NxStage Medical
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NxStage System One in people with Kidney Failure, Chronic and End-Stage Renal Disease, run by NxStage Medical at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases. (time frame: Study Week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00667511, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015.