Trial Outcomes & Findings for An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System (NCT NCT04198012)
NCT ID: NCT04198012
Last Updated: 2025-09-08
Results Overview
The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
52 weeks
Results posted on
2025-09-08
Participant Flow
Participant milestones
| Measure |
The HemoCare™ Hemodialysis System
All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System
Baseline characteristics by cohort
| Measure |
The HemoCare™ Hemodialysis System
n=25 Participants
All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will.
|
|---|---|
|
Age, Continuous
|
48.24 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 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
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksThe Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.
Outcome measures
| Measure |
The HemoCare™ Hemodialysis System
n=25 Participants
All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will.
|
|---|---|
|
Number of Subjects With Safety Event
Anticipated Adverse Event
|
20 participants
|
|
Number of Subjects With Safety Event
Unanticipated Adverse Event
|
20 participants
|
|
Number of Subjects With Safety Event
Device-Related Adverse Event
|
5 participants
|
|
Number of Subjects With Safety Event
Anticipated Serious Adverse Event
|
6 participants
|
|
Number of Subjects With Safety Event
Unanticipated Serious Adverse Event
|
12 participants
|
|
Number of Subjects With Safety Event
Device Related Serious Adverse Event
|
0 participants
|
Adverse Events
The HemoCare™ Hemodialysis System
Serious events: 15 serious events
Other events: 22 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
The HemoCare™ Hemodialysis System
n=25 participants at risk
All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will.
|
|---|---|
|
General disorders
Chest discomfort
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Cardiac disorders
Bradycardia
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Endocrine disorders
Hyperparathyroidism
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Abscess limb
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Cellulitis
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Cystitis
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Pneumonia
|
12.0%
3/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
4.0%
1/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
SARS-CoV-2 test positive
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hypervolemia
|
12.0%
3/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Bell's palsy
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
4.0%
1/25 • Number of events 1 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Surgical and medical procedures
Renal transplant
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
Other adverse events
| Measure |
The HemoCare™ Hemodialysis System
n=25 participants at risk
All subjects who complete DEKA Protocol DKPL-00057-001 and meet all of the inclusion criteria and exclusion criteria will.
|
|---|---|
|
Cardiac disorders
Palpitations
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
2/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • Number of events 4 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 4 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
General disorders
Chest pain
|
8.0%
2/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Conjunctivitis
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Influenza
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Localized infection
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Sinusitis
|
12.0%
3/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Post procedural hemorrhage
|
8.0%
2/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access site hemorrhage
|
12.0%
3/25 • Number of events 4 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
12.0%
3/25 • Number of events 4 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood phosphorus increased
|
8.0%
2/25 • Number of events 3 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Blood potassium increased
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Hemoglobin decreased
|
16.0%
4/25 • Number of events 5 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Investigations
Heart rate increased
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
32.0%
8/25 • Number of events 9 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
12.0%
3/25 • Number of events 12 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
5/25 • Number of events 28 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
12.0%
3/25 • Number of events 6 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
16.0%
4/25 • Number of events 5 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 4 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
5/25 • Number of events 18 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Dizziness
|
20.0%
5/25 • Number of events 7 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Headache
|
16.0%
4/25 • Number of events 6 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Nervous system disorders
Hypoesthesia
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Product Issues
Thrombosis in device
|
8.0%
2/25 • Number of events 2 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.0%
3/25 • Number of events 4 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25 • Number of events 7 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Vascular disorders
Hemorrhage
|
24.0%
6/25 • Number of events 12 • During study participation - from the time of consent until the end of participation (on average 1 year)
All Adverse Events and Serious Adverse Events were recorded, regardless of relatedness.
|
|
Vascular disorders
Hypotension
|
32.0%
8/25 • Number of events 9 • During study participation - from the time of consent until the end of participation (on average 1 year)
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