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Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™

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ClinicalTrials.gov Identifier: NCT00667511
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : January 14, 2015
Last Update Posted : January 14, 2015
Sponsor:
Information provided by (Responsible Party):
NxStage Medical

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Failure, Chronic
End-Stage Renal Disease
Intervention Device: NxStage System One
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis
Hide 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: Training/Transition Period
Started 51
Completed 43
Not Completed 8
Period Title: Intervention 2: Home NHD
Started 43
Completed 39
Not Completed 4
Arm/Group Title Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis
Hide 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 Number of Baseline Participants 58
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants
53  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants
Female
20
  34.5%
Male
38
  65.5%
1.Primary Outcome
Title Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all electronically captured treatments.
Arm/Group Title Home Short Daily Hemodialysis Home Nocturnal Hemodialysis
Hide 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.
Overall Number of Participants Analyzed 58 43
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
1866 1431
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of successful treatments
90.9
(89.2 to 92.6)
91.7
(89.9 to 93.5)
2.Primary Outcome
Title Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
Hide Description The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
Time Frame Study Week 20
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes all patient reported treatments.
Arm/Group Title Home Short Daily Hemodialysis Home Nocturnal Hemodialysis
Hide 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.
Overall Number of Participants Analyzed 58 43
Overall Number of Units Analyzed
Type of Units Analyzed: Treatments
2373 1792
Measure Type: Number
Unit of Measure: events per 100 treatments
8.3 6.9
Time Frame Adverse events were reported during the 20 week period of study participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Home Short Daily Hemodialysis Nocturnal Home Hemodialysis
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Home Short Daily Hemodialysis Nocturnal Home Hemodialysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/58 (22.41%)      5/43 (11.63%)    
Cardiac disorders     
Angina/Chest Pain *  2/58 (3.45%)  2 0/43 (0.00%)  0
Gastrointestinal disorders     
Colitis *  0/58 (0.00%)  0 1/43 (2.33%)  1
General disorders     
Infection *  2/58 (3.45%)  2 2/43 (4.65%)  2
Abdominal Pain *  1/58 (1.72%)  2 0/43 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal Injuries * [1]  6/58 (10.34%)  6 0/43 (0.00%)  0
Renal and urinary disorders     
Hypertension *  1/58 (1.72%)  1 0/43 (0.00%)  0
Surgical and medical procedures     
Eye surgery * [2]  0/58 (0.00%)  0 1/43 (2.33%)  1
Vascular disorders     
Vascular Access Issues *  4/58 (6.90%)  6 1/43 (2.33%)  2
Cerebrovascular Accident *  1/58 (1.72%)  1 0/43 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Non-dialysis related joint sprains, tears, and fractures
[2]
non-dialysis related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Home Short Daily Hemodialysis Nocturnal Home Hemodialysis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/58 (68.97%)      30/43 (69.77%)    
Gastrointestinal disorders     
Diarrhea *  0/58 (0.00%)  0 5/43 (11.63%)  8
General disorders     
Cold/Flu-like Symptoms *  12/58 (20.69%)  17 6/43 (13.95%)  8
Other * [1]  9/58 (15.52%)  26 4/43 (9.30%)  20
Clotted Dialysis Blood Lines *  0/58 (0.00%)  0 3/43 (6.98%)  3
Fatigue *  3/58 (5.17%)  4 4/43 (9.30%)  5
General Bodily Pain * [2]  2/58 (3.45%)  4 3/43 (6.98%)  4
Renal and urinary disorders     
Hypotension/Hypovolemia/Cramping *  22/58 (37.93%)  71 13/43 (30.23%)  26
Dialysis-related blood loss *  5/58 (8.62%)  6 3/43 (6.98%)  5
Vascular disorders     
Vascular Access Problems * [3]  12/58 (20.69%)  20 8/43 (18.60%)  16
*
Indicates events were collected by non-systematic assessment
[1]
other singular non-dialysis-related events
[2]
i.e. shoulder pain, back pain
[3]
i.e. poor access flow, painful access, bleeding
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kristen Sheppard
Organization: NxStage Medical, Inc.
Phone: 978-687-4700
Responsible Party: NxStage Medical
ClinicalTrials.gov Identifier: NCT00667511     History of Changes
Other Study ID Numbers: CP0010
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: December 22, 2014
Results First Posted: January 14, 2015
Last Update Posted: January 14, 2015