NCT00667511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 14, 2015

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

6.1 years

First QC Date

April 24, 2008

Results QC Date

December 22, 2014

Last Update Submit

January 12, 2015

Conditions

Kidney Failure, ChronicEnd-Stage Renal Disease

Keywords

ESRDEnd Stage Renal DiseaseDaily HemodialysisNocturnal HemodialysisHemodialysisKidney FailureKidney Disease

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

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.

Device: NxStage System One

Interventions

NxStage System OneDEVICE

Comparison of Nocturnal (NHD) and Short Daily Hemodialysis (DHD) with the NxStage System One

Home Nocturnal HemodialysisHome Short Daily Hemodialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a stable prescription in the short daily home environment using the NxStage System One prior to enrollment.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Satellite Healthcare/Wellbound

San Jose, California, 95128, United States

Location

Circle Medical Management

Chicago, Illinois, 60607, United States

Location

Indiana University Dialysis Center

Indianapolis, Indiana, 46202, United States

Location

Kansas Nephrology Research Institute, LLC

Wichita, Kansas, 67214, United States

Location

Barnes Jewish Dialysis Center

St Louis, Missouri, 63110, United States

Location

Dialysis Center of Lincoln

Lincoln, Nebraska, 68512, United States

Location

Rubin Dialysis

Saratoga Springs, New York, 12866, United States

Location

DaVita Grapevine at Home

Grapevine, Texas, 76051, United States

Location

DaVita Bluemound Home Dialysis

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (1)

  • 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. doi: 10.2215/CJN.0000000927. Online ahead of print. No abstract available.

    PMID: 41071621DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicRenal InsufficiencyKidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Kristen Sheppard
Organization
NxStage Medical, Inc.
978-687-4700

Study Officials

  • Paul Kravitz

    NxStage Medical

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 14, 2015

Results First Posted

January 14, 2015

Record last verified: 2015-01

Locations

US(9)