Trial Outcomes & Findings for Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™ (NCT NCT00667511)
NCT ID: NCT00667511
Last Updated: 2015-01-14
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Study Week 20
Results posted on
2015-01-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Intervention 1: Home DHD
STARTED
|
58
|
|
Intervention 1: Home DHD
COMPLETED
|
51
|
|
Intervention 1: Home DHD
NOT COMPLETED
|
7
|
|
Training/Transition Period
STARTED
|
51
|
|
Training/Transition Period
COMPLETED
|
43
|
|
Training/Transition Period
NOT COMPLETED
|
8
|
|
Intervention 2: Home NHD
STARTED
|
43
|
|
Intervention 2: Home NHD
COMPLETED
|
39
|
|
Intervention 2: Home NHD
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
Baseline characteristics by cohort
| Measure |
Home Short Daily Hemodialysis Then Home Nocturnal Hemodialysis
n=58 Participants
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.
|
|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Week 20Population: Includes all electronically captured treatments.
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).
Outcome measures
| Measure |
Home Short Daily Hemodialysis
n=1866 Treatments
Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
|
Home Nocturnal Hemodialysis
n=1431 Treatments
Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
|
|---|---|---|
|
Primary Efficacy: Compare the Ability to Deliver the Clinically Prescribed Amount of Therapy in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
|
90.9 percentage of successful treatments
Interval 89.2 to 92.6
|
91.7 percentage of successful treatments
Interval 89.9 to 93.5
|
PRIMARY outcome
Timeframe: Study Week 20Population: Includes all patient reported treatments.
The primary safety endpoint for the study was the composite intradialytic and interdialytic adverse event (AE) profile.
Outcome measures
| Measure |
Home Short Daily Hemodialysis
n=2373 Treatments
Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
|
Home Nocturnal Hemodialysis
n=1792 Treatments
Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
|
|---|---|---|
|
Primary Safety: Compare the Composite Intradialytic and Interdialytic Adverse Event Profile in the Nocturnal Hemodialysis and Short Daily Hemodialysis Phases.
|
8.3 events per 100 treatments
|
6.9 events per 100 treatments
|
Adverse Events
Home Short Daily Hemodialysis
Serious events: 13 serious events
Other events: 40 other events
Deaths: 0 deaths
Nocturnal Home Hemodialysis
Serious events: 5 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home Short Daily Hemodialysis
n=58 participants at risk
Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
|
Nocturnal Home Hemodialysis
n=43 participants at risk
Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
|
|---|---|---|
|
Cardiac disorders
Angina/Chest Pain
|
3.4%
2/58 • Number of events 2 • Adverse events were reported during the 20 week period of study participation.
|
0.00%
0/43 • Adverse events were reported during the 20 week period of study participation.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Injuries
|
10.3%
6/58 • Number of events 6 • Adverse events were reported during the 20 week period of study participation.
|
0.00%
0/43 • Adverse events were reported during the 20 week period of study participation.
|
|
Renal and urinary disorders
Hypertension
|
1.7%
1/58 • Number of events 1 • Adverse events were reported during the 20 week period of study participation.
|
0.00%
0/43 • Adverse events were reported during the 20 week period of study participation.
|
|
Vascular disorders
Vascular Access Issues
|
6.9%
4/58 • Number of events 6 • Adverse events were reported during the 20 week period of study participation.
|
2.3%
1/43 • Number of events 2 • Adverse events were reported during the 20 week period of study participation.
|
|
General disorders
Infection
|
3.4%
2/58 • Number of events 2 • Adverse events were reported during the 20 week period of study participation.
|
4.7%
2/43 • Number of events 2 • Adverse events were reported during the 20 week period of study participation.
|
|
General disorders
Abdominal Pain
|
1.7%
1/58 • Number of events 2 • Adverse events were reported during the 20 week period of study participation.
|
0.00%
0/43 • Adverse events were reported during the 20 week period of study participation.
|
|
Vascular disorders
Cerebrovascular Accident
|
1.7%
1/58 • Number of events 1 • Adverse events were reported during the 20 week period of study participation.
|
0.00%
0/43 • Adverse events were reported during the 20 week period of study participation.
|
|
Surgical and medical procedures
Eye surgery
|
0.00%
0/58 • Adverse events were reported during the 20 week period of study participation.
|
2.3%
1/43 • Number of events 1 • Adverse events were reported during the 20 week period of study participation.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/58 • Adverse events were reported during the 20 week period of study participation.
|
2.3%
1/43 • Number of events 1 • Adverse events were reported during the 20 week period of study participation.
|
Other adverse events
| Measure |
Home Short Daily Hemodialysis
n=58 participants at risk
Intervention 1: Patients perform short daily hemodialysis (2 to 4 hour treatments) in the home setting using the NxStage System One.
|
Nocturnal Home Hemodialysis
n=43 participants at risk
Intervention 2: Patients perform nocturnal hemodialysis (6 to 10 hour treatments) in the home setting using the NxStage System One.
|
|---|---|---|
|
General disorders
Cold/Flu-like Symptoms
|
20.7%
12/58 • Number of events 17 • Adverse events were reported during the 20 week period of study participation.
|
14.0%
6/43 • Number of events 8 • Adverse events were reported during the 20 week period of study participation.
|
|
General disorders
Other
|
15.5%
9/58 • Number of events 26 • Adverse events were reported during the 20 week period of study participation.
|
9.3%
4/43 • Number of events 20 • Adverse events were reported during the 20 week period of study participation.
|
|
General disorders
Clotted Dialysis Blood Lines
|
0.00%
0/58 • Adverse events were reported during the 20 week period of study participation.
|
7.0%
3/43 • Number of events 3 • Adverse events were reported during the 20 week period of study participation.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/58 • Adverse events were reported during the 20 week period of study participation.
|
11.6%
5/43 • Number of events 8 • Adverse events were reported during the 20 week period of study participation.
|
|
Vascular disorders
Vascular Access Problems
|
20.7%
12/58 • Number of events 20 • Adverse events were reported during the 20 week period of study participation.
|
18.6%
8/43 • Number of events 16 • Adverse events were reported during the 20 week period of study participation.
|
|
Renal and urinary disorders
Hypotension/Hypovolemia/Cramping
|
37.9%
22/58 • Number of events 71 • Adverse events were reported during the 20 week period of study participation.
|
30.2%
13/43 • Number of events 26 • Adverse events were reported during the 20 week period of study participation.
|
|
Renal and urinary disorders
Dialysis-related blood loss
|
8.6%
5/58 • Number of events 6 • Adverse events were reported during the 20 week period of study participation.
|
7.0%
3/43 • Number of events 5 • Adverse events were reported during the 20 week period of study participation.
|
|
General disorders
Fatigue
|
5.2%
3/58 • Number of events 4 • Adverse events were reported during the 20 week period of study participation.
|
9.3%
4/43 • Number of events 5 • Adverse events were reported during the 20 week period of study participation.
|
|
General disorders
General Bodily Pain
|
3.4%
2/58 • Number of events 4 • Adverse events were reported during the 20 week period of study participation.
|
7.0%
3/43 • Number of events 4 • Adverse events were reported during the 20 week period of study participation.
|
Additional Information
Kristen Sheppard
NxStage Medical, Inc.
Phone: 978-687-4700
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60