Trial Outcomes & Findings for Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD (NCT NCT04087213)
NCT ID: NCT04087213
Last Updated: 2024-08-13
Results Overview
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
31 weeks
Results posted on
2024-08-13
Participant Flow
A required introduction to the HemoCare hemodialysis system and successful training for cannulation/ vascular access care at the study site for a minimum of 1-week prior to first home treatment (In-Facility Introduction Period).
Participant milestones
| Measure |
Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Assisted: In-home treatment administered by a medical professional.
Unassisted: In-home treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|
|
In-Facility Introduction
STARTED
|
36
|
|
In-Facility Introduction
COMPLETED
|
34
|
|
In-Facility Introduction
NOT COMPLETED
|
2
|
|
Transition Period A
STARTED
|
34
|
|
Transition Period A
COMPLETED
|
34
|
|
Transition Period A
NOT COMPLETED
|
0
|
|
Assisted Evaluable Period
STARTED
|
34
|
|
Assisted Evaluable Period
COMPLETED
|
29
|
|
Assisted Evaluable Period
NOT COMPLETED
|
5
|
|
Transition Period B
STARTED
|
29
|
|
Transition Period B
COMPLETED
|
28
|
|
Transition Period B
NOT COMPLETED
|
1
|
|
Unassisted Home Evaluable Period
STARTED
|
28
|
|
Unassisted Home Evaluable Period
COMPLETED
|
28
|
|
Unassisted Home Evaluable Period
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Assisted: In-home treatment administered by a medical professional.
Unassisted: In-home treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|
|
In-Facility Introduction
Withdrawal by Subject
|
1
|
|
In-Facility Introduction
Adverse Event
|
1
|
|
Assisted Evaluable Period
Withdrawal by Subject
|
2
|
|
Assisted Evaluable Period
Personal reasons
|
3
|
|
Transition Period B
Renal Transplantation
|
1
|
Baseline Characteristics
Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD
Baseline characteristics by cohort
| Measure |
Intent-To-Treat (ITT) Population
n=34 Participants
The ITT population was defined as all subjects who used HemoCare Hemodialysis System at least once during the Assisted Evaluable Period.
|
|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 31 weeksPopulation: The ITT population was defined as all subjects who used HemoCare Hemodialysis System at least once during the Assisted Evaluable Period.
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Outcome measures
| Measure |
Assisted Evaluable Period
n=34 Participants
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 Participants
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
Primary Safety Endpoint
|
16.1 Adverse Events per 100 Treatments
|
11.6 Adverse Events per 100 Treatments
|
PRIMARY outcome
Timeframe: 31 weeksPopulation: Weekly stdKt/Vurea collected from the Intent-To-Treat (ITT) Population
Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0.
Outcome measures
| Measure |
Assisted Evaluable Period
n=34 Participants
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 Participants
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
Primary Performance Endpoint
|
1 Percentage of subjects with Kt/V ≥ 2.0
Interval 0.92 to 1.0
|
1 Percentage of subjects with Kt/V ≥ 2.0
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: 31 weeksPopulation: Adverse Events reported by the Intent-To-Treat (ITT) Population
Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs.
Outcome measures
| Measure |
Assisted Evaluable Period
n=34 Participants
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 Participants
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Total Adverse Events
|
204 events
|
139 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Anticipated Non-Serious AE
|
148 events
|
11 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Anticipated Serious AE
|
5 events
|
2 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Unanticipated Non-Serious AE
|
49 events
|
26 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Unanticipated Serious AE
|
2 events
|
0 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Device-Related Non-Serious AE
|
27 events
|
7 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Device-Related Serious AE
|
0 events
|
0 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Unanticipated Device-Related Non-Serious AE
|
0 events
|
0 events
|
|
The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Unanticipated Device-Related Serious AE
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: 31 weeksPopulation: Intent-To-Treat (ITT) Population
The number of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level \< 2.2 mg/dL , the number of elevated serum phosphorous defined as a least 1 post-dialysis serum phosphorus level \> 5.5 mg/dL, will each be compared between Evaluable Periods with exact McNemar's tests.
Outcome measures
| Measure |
Assisted Evaluable Period
n=34 Participants
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 Participants
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
Decreased serum phosphorous
|
48 occurrence of event
|
32 occurrence of event
|
|
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
Increased serum phosphorous
|
0 occurrence of event
|
2 occurrence of event
|
SECONDARY outcome
Timeframe: 31 weeksPopulation: Intent-To-Treat (ITT) Population
The number of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of \< 3.5 meq/L , and the number of elevated serum potassium defined as at least 1 post-dialysis serum potassium level of \> 5.9 meq/L, will each be compared between Evaluable Periods with exact McNemar's tests.
Outcome measures
| Measure |
Assisted Evaluable Period
n=34 Participants
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 Participants
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
Decreased serum potassium
|
43 events
|
24 events
|
|
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
Elevated serum potassium
|
0 events
|
1 events
|
SECONDARY outcome
Timeframe: 31 weeksPopulation: Intent-To-Treat (ITT) Population
HemoCare Ultrafiltration Comparison by Evaluable Period was determined by the following: Discrepancy between Weight Change and Net UF removed = Weight change - Net UF Removed Weight change = Ending weight - Starting weight (measured by digital weight scale). Net Ultrafiltration Removed = total UF removed - prime \& rinseback, reported by the HemoCare system. Note: One kilogram (kg) = one liter (L) of fluid
Outcome measures
| Measure |
Assisted Evaluable Period
n=34 Participants
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 Participants
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
Weight Change and Fluid Removed Comparison Between Evaluable Periods
|
0.1 L
Standard Deviation 3.5
|
0.1 L
Standard Deviation 1.1
|
Adverse Events
Assisted Evaluable Period
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Unassisted Home Evaluable Period
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Assisted Evaluable Period
n=34 participants at risk
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 participants at risk
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
Infections and infestations
Bacteremia
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
0.00%
0/34 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
3.6%
1/28 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hypervolemia
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
3.6%
1/28 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Number of events 1 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
Other adverse events
| Measure |
Assisted Evaluable Period
n=34 participants at risk
In-home treatment administered by a medical professional.
|
Unassisted Home Evaluable Period
n=28 participants at risk
In-home HD treatments either self-administered with the assistance of a care partner or administered by a care partner
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/34 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
10.7%
3/28 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Diarrhea
|
20.6%
7/34 • Number of events 7 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
17.9%
5/28 • Number of events 5 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Nausea
|
17.6%
6/34 • Number of events 6 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
14.3%
4/28 • Number of events 6 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
10.7%
3/28 • Number of events 4 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
General disorders
Chest pain
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
General disorders
Chills
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
General disorders
Fatigue
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
General disorders
Edema
|
5.9%
2/34 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
General disorders
Edema peripheral
|
8.8%
3/34 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
8.8%
3/34 • Number of events 7 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 6 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site hematoma
|
5.9%
2/34 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
8.8%
3/34 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access site hemorrhage
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
14.7%
5/34 • Number of events 5 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood calcium decreased
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood glucose increased
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood phosphorus decreased
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
10.7%
3/28 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/34 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood potassium increased
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Hemoglobin decreased
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/34 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
11.8%
4/34 • Number of events 5 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
14.3%
4/28 • Number of events 6 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.7%
5/34 • Number of events 6 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
0.00%
0/28 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
17.6%
6/34 • Number of events 9 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 4 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
26.5%
9/34 • Number of events 13 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
21.4%
6/28 • Number of events 11 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/34 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Dizziness
|
20.6%
7/34 • Number of events 8 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
14.3%
4/28 • Number of events 7 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Headache
|
23.5%
8/34 • Number of events 10 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
21.4%
6/28 • Number of events 15 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Product Issues
Thrombosis in device
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Vascular disorders
Hemorrhage
|
23.5%
8/34 • Number of events 25 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
7.1%
2/28 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Vascular disorders
Hypotension
|
5.9%
2/34 • Number of events 2 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
10.7%
3/28 • Number of events 3 • During the study period - from the time of enrollment until the end of participation in the study (31 weeks).
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER