Renal DialysisNCT05217095
Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
A study testing Convergence Dialyzer in people with Renal Dialysis, run by D.med Consulting GmbH at 1 site in North Macedonia.
Trial summary
The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Convergence Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 19 Jan 2022to 22 Feb 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be up to 18-85 years
- Hemodialysis Schedule: 3 times per week; app. 3- 5 hour treatment
- Stable clinical conditions: no recent (last 2 weeks) hospitalization events, no recent main surgery (last 3 weeks), no acute cardiological problems, hemoglobine levels in the DOQI Guideline ranges.
- Hemodynamic stability during dialysis i.c. number of sessions complicated by acute hypotension events or arrhythmia <25% in the last 3 Months
- Well-functioning AVF vascular access: access recirculation ≤10%
- No coagulation disorders and anticoagulant therapy
- Patients must be using a similar size dialyzer as Convergence dialyzer
- Signed Inform consent form.
Who cannot join
- Unstable clinical condition: recent hospitalization, recent surgery, anemia, active neoplastic diseases,shock or unstable cardiac function and intolerable to extracorporeal treatment
- Hemodynamic instability during the dialysis sessions; more than 25% of the sessions complicated by acute hypotension or arrhythmic events.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study.
- History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study Convergence system treatment.
- Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal.
- Any uncontrolled clinically significant respiratory disease in the investigator's opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma).
- Temporary excluded will be patients with increased body temperature due to some infective disease, dehydration, diarrhea, hyperglycemia,
Show all 14Show fewer
- Severe bleeding, or history or evidence of bleeding diathesis or coagulopathy with the risk of bleeding or have to put on dialysis without anticoagulant.
- Using temporary or permanent dialysis catheter
- Uncontrolled diabetes mellitus or hypertension, at the discretion of investigator.
- Known pregnancy and lactating without pregnancy test
- Patient has known allergy or hypersensitivity reaction to dialyzer membrane or other disposable
- Any conditions significantly affecting the nervous system (i.e., neuropathic conditions or nervous system damage
- Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply with the protocol requirements in the opinion of the investigator
- Any other conditions at the discretion of investigator not suitable for patients to participate in the study
Trial locations and contacts
1 site in 1 country.
North Macedonia1 site
Special Hospital for Nephrology and Dialysis Diamed
Skopje, 1000
About this study
The aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.
- Conditions
- Renal Dialysis
- Being tested
- Convergence Dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convergence DialyzerDevice
The Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Other | Each patient will be treated for one session of dialysis after enrolled. Each of them will have only one treatment in the middle of the week (Wednesday or Thursday). The patients will be treated using 4008A dialysis machines in combination with a sidecar and the convergence dialyzer as investigational devices.Each patient will be treated according their regular treatment and laboratory analysis will be taken. The blood level of free hemoglobin ( fHb ) will be taken on 30 min by use of HemoCue device. ACT time will be measured on 15 min and for that 0.5 ml blood from venous line will be taken. Receives: Device: Convergence Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Alarms
Incidence of alarms leading to end of treatment, cause identification
Measured: 1 study day
Product defects
Product defects leading to end of treatment, cause identification
Measured: 1 study day
Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Measured: 1 study day
Incidence of "recoverable" alarms
Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits
Measured: 1 study day
Secondary outcomes (17)
Completion Rate
The completion rate of a dialysis session according to prescription. The study is considered to be successful, if at least 8 patients reach the effective dialysis time.
Measured: 1 study day
Average Blood Flow Rate
The average blood flow rate is measured during the dialysis treatment. Maintenance of preset blood flow rates throughout the dialysis in at least 8 out of 10 patients
Measured: 1 study day
Arterial pressure
The arterial pressure is measured in mmHg.
Measured: 1 study day
Venous pressure
The venous pressure is measured in mmHg.
Measured: 1 study day
Impeller RPM
The rotation of the impeller pump is measured in rpm.
Measured: 1 study day
Dialysis Dose as single pool Kt/V
The delivered dialysis dose as single-pool Kt/V. Achievement of a spKt/V > 1.4 in at least 8 out of 10 patients.
Measured: 1 study day
Dialysis Dose as Urea Reduction Ratio (URR)
The delivered dialysis dose as URR.
Measured: 1 study day
Ultrafiltration Volume
Total ultrafiltration volume (ml). Achievement of preset total ultrafiltration volume (ml) to reach dry weight target in at least 8 out of 10 patients.
Measured: 1 study day
Body weight change
Patient body weight change (before treatment vs. after treatment).
Measured: 1 study day
pH
The blood level of pH is measured pre/post HD. Achievement of results in laboratory acceptable ranges,
Measured: 1 study day
Bicarbonate
The blood level of Bicarbonate is measured pre/post HD. Achievement of results in laboratory acceptable ranges.
Measured: 1 study day
Potassium
The blood level of Potassium is measured pre/post HD. Achievement of results in laboratory acceptable ranges,
Measured: 1 study day
Sodium
The blood level of Sodium is measured pre/post HD. Achievement of results in laboratory acceptable ranges.
Measured: 1 study day
Chloride
The blood level of Chloride is measured pre/post HD. Achievement of results in laboratory acceptable ranges.
Measured: 1 study day
Free hemoglobin
The blood level of free hemoglobin (fHb measured on 30 min) to be in acceptable ranges for hemolysis
Measured: 1 study day
Anticoagulation
The total dose of anticoagulation consumption not to exceed patient treatment dose as I.U per kg
Measured: 1 study day
Clotting Score
The clotting score of dialyzer(visual check, using common scale for dialyzer study)
- No visible thrombosed fibers
- A few visible thrombosed fibers
- Moderately visible thrombosed fibers
- Many visible thrombosed fibers
- Completely visible thrombosed fibers
So the score goes from 1 (good) to 5 (bad).
Measured: 1 study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start19 Jan 2022
- Primary completion22 Jan 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- D.med Consulting GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Responsible party
- Sponsor
- Investigators
- Elena Babalj-Banskolieva, Dr., Principal investigator, Specialized Hospital for Nephrology and Dialysis Diamed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217095
- Sponsor's protocol ID
- D.Med 20-01 Convergence
- Status last verified
- Feb 2022
- First submitted
- 13 Dec 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on a Novel Blood Pumping System in 4008A Hemodialysis Machine
- ClinicalTrials.gov ID
- NCT05217095
- Acronym / sponsor ID
- D.Med 20-01 Convergence
- Conditions
- Renal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- D.med Consulting GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Fresenius Medical Care Deutschland GmbH
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 1 Feb 2022 (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 aim of this clinical trial will be to verify the feasibility of using an impeller system instead of a roller pump for hemodialysis, using the established 4008 hemodialysis system and a Convergence Dialyzer with design changes made to the FX-Coral P 600 dialyzer.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Other | Device: Convergence DialyzerEach patient will be treated for one session of dialysis after enrolled. Each of them will have only one treatment in the middle of the week (Wednesday or Thursday). The patients will be treated using 4008A dialysis machines in combination with a sidecar and the convergence dialyzer as investigational devices.Each patient will be treated according their regular treatment and laboratory analysis will be taken. The blood level of free hemoglobin ( fHb ) will be taken on 30 min by use of HemoCue device. ACT time will be measured on 15 min and for that 0.5 ml blood from venous line will be taken. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be up to 18-85 years
- Hemodialysis Schedule: 3 times per week; app. 3- 5 hour treatment
- Stable clinical conditions: no recent (last 2 weeks) hospitalization events, no recent main surgery (last 3 weeks), no acute cardiological problems, hemoglobine levels in the DOQI Guideline ranges.
- Hemodynamic stability during dialysis i.c. number of sessions complicated by acute hypotension events or arrhythmia <25% in the last 3 Months
- Well-functioning AVF vascular access: access recirculation ≤10%
Key exclusion criteria (14 listed)
- Unstable clinical condition: recent hospitalization, recent surgery, anemia, active neoplastic diseases,shock or unstable cardiac function and intolerable to extracorporeal treatment
- Hemodynamic instability during the dialysis sessions; more than 25% of the sessions complicated by acute hypotension or arrhythmic events.Presence of clinically significant abnormality on a 12-lead ECG at Screening that, at the investigator's clinical judgment, may compromise the safety of the patient or affect the outcome of the study.
- History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study Convergence system treatment.
- Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal.
- Any uncontrolled clinically significant respiratory disease in the investigator's opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma).
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 |
|---|---|---|
| Convergence DialyzerThe Convergence dialyzer with design changes made to FX Coral 600 dialyzer will be tested together with Sidecar. In the dialyzer is integrated centrifugal-flow blood pump.The centrifugal-flow blood pump replaces the peristaltic roller pump of the extracorporeal circuit which pumps blood from patient to the dialyzer and from dialyzer to the patient. The centrifugal-flow blood pump is designed to transport blood from the patient to the dialyzer, and after purification, return the blood to patient. | Device | Interventional Group |
Primary outcome
Incidence of Alarms
Time frame: 1 study day
Incidence of alarms leading to end of treatment, cause identification
Product defects
Time frame: 1 study day
Product defects leading to end of treatment, cause identification
Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Time frame: 1 study day
Incidence of Serious adverse event / adverse event/ Serious adverse device effect/ Adverse device effect/Unanticipated serious adverse device effect
Incidence of "recoverable" alarms
Time frame: 1 study day
Incidence of "recoverable" alarms, cause of alarms i.e.arterial/venous pressure outside of set range/limits
17 secondary outcomes
Completion Rate
Time frame: 1 study day
Average Blood Flow Rate
Time frame: 1 study day
Arterial pressure
Time frame: 1 study day
Venous pressure
Time frame: 1 study day
Impeller RPM
Time frame: 1 study day
Dialysis Dose as single pool Kt/V
Time frame: 1 study day
Dialysis Dose as Urea Reduction Ratio (URR)
Time frame: 1 study day
Ultrafiltration Volume
Time frame: 1 study day
Body weight change
Time frame: 1 study day
pH
Time frame: 1 study day
Bicarbonate
Time frame: 1 study day
Potassium
Time frame: 1 study day
Sodium
Time frame: 1 study day
Chloride
Time frame: 1 study day
Free hemoglobin
Time frame: 1 study day
Anticoagulation
Time frame: 1 study day
Clotting Score
Time frame: 1 study day
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 2 Mar 2022.
- 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.
Elena Babalj-Banskolieva, Dr. principal investigator
Specialized Hospital for Nephrology and Dialysis Diamed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Convergence Dialyzer in people with Renal Dialysis, run by D.med Consulting GmbH at 1 site in North Macedonia.
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 8 inclusion and 14 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in North Macedonia. 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?
Incidence of Alarms (time frame: 1 study day). The study lists 4 primary outcomes in all. 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 2 Mar 2022.