DialysisHEMONCT04655989
A Study to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System
A study testing DBB-EXA ES Hemodialysis System in people with Dialysis and Chronic Renal Failure, run by Nikkiso America, Inc. at 2 sites in United States.
Trial summary
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis, Chronic Renal Failure
- What is being tested?
- DBB-EXA ES Hemodialysis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age
- Chronic renal failure diagnosis
- Minimum of 90 days of stable hemodialysis treatment with a minimum of 3 treatment sessions per week. The duration of each treatment session is in the discretion of the investigator.
- Reliable vascular access
- Hemodialysis treatment a minimum of three (3) sessions per week
- Subject agrees not to eat or drink during treatments
- Understand and sign the informed consent form
Who cannot join
- Unable to receive anticoagulation
- Hypercoagulation diagnosis
- Hyperviscosity diagnosis
- Most recent hemoglobin less than 9
- Active bacterial infection
- Women of childbearing potential, pregnant and/or lactating females verified by urine or serum pregnancy test
Show all 12Show fewer
- Life expectancy less than 6 months
- Cognitive impairment, dementia, or other condition that limits the ability to provide informed consent and to comply with study procedures, or any other reason that the Investigator believes to contraindicate study participation.
- Current or known future need for a central venous catheter (CVC)
- Involved in another clinical research trial within the prior 30 days
- Diagnosed with systemic consistent hypotension as defined by being systolic <90 mm Hg or diastolic <60 mm Hg
- Immunocompromised patients (e.g. active malignancy, current chemotherapy treatment, transplant recipients, any patient on immunosuppressive medication, or patients with current autoimmune disease).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Great Lakes Dialysis
Detroit, Michigan, 48215
Great Lakes Dialysis - West
Southfield, Michigan, 48033
About this study
Official title: A Prospective, Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System in Adult Patients With Chronic Renal Failure
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.
Read the detailed description
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion. The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).
The study population will include eligible adult patients diagnosed with chronic renal failure requiring routine dialysis treatments for a minimum of 90 days and with a minimum of 3 weekly sessions. Treatment duration will be at the discretion of the investigator. The duration of study participation for each subject is approximately eight (8) weeks; four (4) weeks of routine dialysis and four (4) weeks of treatment dialysis. The expected total study duration across all subjects (from recruitment to last subject visits) is approximately five (5) to six (6) months, dependent upon subject recruitment/enrollment and meeting 360 evaluable treatments. A minimum of 30 eligible subjects will be enrolled into the study ensuring a minimum of 360 evaluable treatments in the treatment arm.
The sub-study, VARRM, was conducted following the subject's completion of the primary eight (8) week clinical study. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Subjects that participated in the VARRM sub-study had their vascular recirculation rates collected during treatments. A minimum of 12 subjects were expected to participate in this sub-study, with a minimum of 21 and maximum of 36 dialysis accesses evaluated.
- Conditions
- Dialysis, Chronic Renal Failure
- Being tested
- DBB-EXA ES Hemodialysis System
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBB-EXA ES Hemodialysis SystemDevice
The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
| Study group | Role | What they receive |
|---|---|---|
| Routine first | Experimental | Group A subjects will be assigned to 4 weeks of routine dialysis (control group) followed by 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group). Receives: Device: DBB-EXA ES Hemodialysis System |
| Investigational first | Experimental | Group B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group). Receives: Device: DBB-EXA ES Hemodialysis System |
| VARRM sub-study | Other | Following completion of the initial 8-week treatment, subject's were eligible to participate in the sub-study, VARRM. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Receives: Device: DBB-EXA ES Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate
The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control)
Measured: 8 weeks
Secondary outcomes (2)
Total Colony Forming Units and Endotoxin Levels
The effectiveness will be evaluated by comparing the total Colony Forming Units (CFUs) and endotoxin levels calculated within dialysis fluid in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).
Measured: 8 Weeks
Fluid Balance Evaluation
The impact that online priming, online rinse back and online emergency bolus, if performed, has on fluid balance will be evaluated by assessing the proportion of subjects that have a Post-Dialysis Target Weight variance of > 0.5kg in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start30 Nov 2020
- Primary completion24 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Group A subjects will be assigned to 4 weeks of routine dialysis (control group) followed by 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group). Group B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group). After completion of the initial 8-week treatment period, subjects were eligible for the Vascular Access Recirculation Rate Measurement (VARRM) sub-study.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nikkiso America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Principal investigator, Robert Provenzano, MD, Nikkiso America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655989
- Sponsor's protocol ID
- DBB-EXA ES-001
- Acronym
- HEMO
- Status last verified
- Sep 2021
- First submitted
- 30 Nov 2020
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized, Controlled Trial to Demonstrate the Safety and Effectiveness of the NIKKISO DBB-EXA ES Hemodialysis Delivery System in Adult Patients With Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT04655989
- Acronym / sponsor ID
- HEMO / DBB-EXA ES-001
- Conditions
- Dialysis, Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Nikkiso America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion.
Detailed description
The study objective is to verify the safety and effectiveness of the DBB-EXA ES Hemodialysis Delivery System to consistently deliver dialysate of the appropriate quality for infusion. The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control).
The study population will include eligible adult patients diagnosed with chronic renal failure requiring routine dialysis treatments for a minimum of 90 days and with a minimum of 3 weekly sessions. Treatment duration will be at the discretion of the investigator. The duration of study participation for each subject is approximately eight (8) weeks; four (4) weeks of routine dialysis and four (4) weeks of treatment dialysis. The expected total study duration across all subjects (from recruitment to last subject visits) is approximately five (5) to six (6) months, dependent upon subject recruitment/enrollment and meeting 360 evaluable treatments. A minimum of 30 eligible subjects will be enrolled into the study ensuring a minimum of 360 evaluable treatments in the treatment arm.
The sub-study, VARRM, was conducted following the subject's completion of the primary eight (8) week clinical study. The total participation time for the VARRM sub-study was approximately 1.5 weeks. Subjects that participated in the VARRM sub-study had their vascular recirculation rates collected during treatments. A minimum of 12 subjects were expected to participate in this sub-study, with a minimum of 21 and maximum of 36 dialysis accesses evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group A subjects will be assigned to 4 weeks of routine dialysis (control group) followed by 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group). Group B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group). After completion of the initial 8-week treatment period, subjects were eligible for the Vascular Access Recirculation Rate Measurement (VARRM) sub-study.
| Arm | Type | Receives |
|---|---|---|
| Routine first | Experimental | Device: DBB-EXA ES Hemodialysis SystemGroup A subjects will be assigned to 4 weeks of routine dialysis (control group) followed by 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group). |
| Investigational first | Experimental | Device: DBB-EXA ES Hemodialysis SystemGroup B subjects will be assigned to 4 weeks of treatment dialysis with the DBB-EXA ES Hemodialysis System (investigational group) followed by 4 weeks of routine dialysis (control group). |
| VARRM sub-study | Other | Device: DBB-EXA ES Hemodialysis SystemFollowing completion of the initial 8-week treatment, subject's were eligible to participate in the sub-study, VARRM. The total participation time for the VARRM sub-study was approximately 1.5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥18 years of age
- Chronic renal failure diagnosis
- Minimum of 90 days of stable hemodialysis treatment with a minimum of 3 treatment sessions per week. The duration of each treatment session is in the discretion of the investigator.
- Reliable vascular access
- Hemodialysis treatment a minimum of three (3) sessions per week
Key exclusion criteria (12 listed)
- Unable to receive anticoagulation
- Hypercoagulation diagnosis
- Hyperviscosity diagnosis
- Most recent hemoglobin less than 9
- Active bacterial infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBB-EXA ES Hemodialysis SystemThe DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback. | Device | Investigational first, Routine first, VARRM sub-study |
Primary outcome
Adverse Event Rate
Time frame: 8 weeks
The safety will be evaluated by comparing the adverse event rate in the DBB-EXA ES Hemodialysis group (investigational) vs. the standard dialysis group (control)
2 secondary outcomes
Total Colony Forming Units and Endotoxin Levels
Time frame: 8 Weeks
Fluid Balance Evaluation
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBB-EXA ES Hemodialysis System in people with Dialysis and Chronic Renal Failure, run by Nikkiso America, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.