HaemofiltrationPhase 1NCT05713188
Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
A Phase 1 study testing MediSieve Magnetic Haemofiltration System in people with Haemofiltration, run by MediSieve Limited at 1 site in Netherlands.
Trial summary
This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemofiltration
- What is being tested?
- MediSieve Magnetic Haemofiltration System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jun 2022to 30 Nov 2022
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, ≥18 and ≤50 years of age
- Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.
Who cannot join
- BMI <18.5 or >30 kg/m2
- Chronic medication use (except contraception)
- Pregnant or lactating females
- Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
- History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)
- History or signs of haematological disease
Show all 28Show fewer
- History or signs of thromboembolic disorders
- History of (intracranial) aneurysmal or haemorrhagic diseases
- History of any disease associated with immune deficiency
- History of cancer in the last 5 years (excluding localised skin cancer or CIS)
- History of heparin-induced thrombocytopenia (HIT)
- History of peptic / gastric ulcer disease
- Family history of haemorrhagic or thromboembolic disorders (<50 years of age)
- Thrombocytopenia (<150*109/ml) or anaemia (males: haemoglobin < 8.0 mmol/L, females: haemoglobin < 7.4 mmol/L)
- History, signs or symptoms of cardiovascular disease, in particular:
- Prone to vagal collapse
- History of atrial or ventricular arrhythmia
- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block
- Hypertension (defined as RR systolic > 160 or RR diastolic > 90 mmHg)
- Hypotension (defined as RR systolic < 100 or RR diastolic < 50 mmHg)
- Renal impairment (defined as plasma creatinine >120 μmol/L)
- Liver enzyme abnormalities (above 2x the upper limit of normal)
- Signs of infection (CRP > 20 mg/L, White Blood Count > 12x109/L or < 4x109/L)
- Clinically significant acute illness, including infections or trauma, within 1 month of the experiment day
- Participation in an experimental intervention or drug trial or donation of blood within 3 months prior to the experiment day
- Recent hospital admission or surgery with general anaesthesia within 3 months prior to experiment day
- Use of recreational drugs within 2 weeks of the experiment day
- Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and/or take part in the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Medical Center
Nijmegen, Gelderland, 6525GA
About this study
This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers
Read the detailed description
The MediSieve Magnetic Haemofiltration System (MMHS) is a system to filter selected moieties from blood in an extracorporeal circuit by magnetic means. Initially, it is developed for the treatment of severe malaria to capture malaria-infected erythrocytes (who are weakly magnetic) to reduce the parasitaemia. However, the use of MMHS can be extended, with the use of antibodies coupled to magnetic beads, to other diseases, such as sepsis.
The MMHS has to be used first in healthy volunteers to determine its clinical safety.
To this end, 6 healthy male and female volunteers (ratio 1:1) will undergo blood filtration using the MediSieve Magnetic Haemofiltration System (without magnetic beads) for five consecutive hours. Vital signs will be continuously monitored and blood samples will be obtained serially to determine laboratory safety and immunological parameters. Furthermore, volunteers will have two follow up visits at 24 hours and 7 days post filtration.
- Conditions
- Haemofiltration
- Being tested
- MediSieve Magnetic Haemofiltration System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediSieve Magnetic Haemofiltration SystemDevice
The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All volunteers will receive the same treatment Receives: Device: MediSieve Magnetic Haemofiltration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse events)
Incidence of (serious) adverse events and device deficiencies during haemofiltration until 7 days post-filtration
Measured: Continuously starting from 2 hours prior of the start of haemofiltration until 7 days post-filtration
Secondary outcomes (16)
Safety (Blood pressure)
Systolic, diastolic and mean arterial pressure will be measured continuously using a radial artery catheter.
Measured: From 2 hours prior until 7 hours after start of haemofiltration.
Safety (Heart rate)
Heart rate will be recorded continuously using a 3-lead ECG.
Measured: Continuously from 2 hours prior until 7 hours after start of haemofiltration.
Safety (Temperature)
Body temperature will be assessed by using tympanic temperature measurements.
Measured: Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.
Safety (Symptoms)
Clinical symptoms will be scored on a Likert scale (ranging from 0 to 5) in a composite endpoint consisting of headache, nausea, shivering, muscle soreness and lower back pain. Higher numbers indicate more severe symptoms.
Measured: Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.
Safety (Immunology)
The following plasma cytokines will be measured (pg/mL): Tumour necrosis factor (TNF), Interleukin (IL)-6, IL-8, IL-10, IL-1 receptor antagonist (IL-1RA), Monocyte Chemoattractant Protein (MCP)-1, Macrophage Inflammatory Protein (MIP)-1α, MIP-1β, Interferon-γ induced Protein (IP)-10, and Granulocyte Colony-Stimulating Factor (G-CSF)
Measured: Samples will be obtained from 1 hour prior until 7 days after start of haemofiltration.
Safety (Metal analysis)
Plasma concentration levels of chromium and manganese will be measured in nmol/L.
Measured: Samples will be obtained from start of haemofiltration, and after 1 hour, 5 hours, 24 hours and 7 days.
Safety (Cell counts)
Leukocytes (including differentation), erythrocytes and thrombocytes will be measured in *10^9/L.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Haemoglobin and elektrolytes)
Haemoglobin, sodium, potassium, calcium, phosphate, magnesium, and urea will be measured in mmol/L
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Haematocrit)
Haematocrit will be measured in L/L.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Coagulation)
Prothrombin time (PT), activated clotting time (ACT) and activated partial thromboplastin time (APTT) will be measured in seconds.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (INR)
International Normalized Ratio (INR) will be measured to assess coagulation.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Fibrinogen + albumin)
Fibrinogen and albumin will be measured in grams/L.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Kidney function)
Kidney function will be measured in mL/min/1.73m^2.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Markers associated with cellular damage)
Cellular damage will be assessed by measuring Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Lactate Dehydrogenase (LDH), Creatine kinase (CK), Alkaline phosphatase (AP)
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (C-reactive protein)
C-reactive protein (CRP) will be measured in mg/L.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Creatinine and iron status)
Creatinine, iron and total iron binding capacity (TIBC) will be measured in umol/L.
Measured: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start13 Jun 2022
- Primary completion17 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemofiltrationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediSieve Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Matthijs Kox, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713188
- Sponsor's protocol ID
- MediSieve FMS study
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Safety of the MediSieve Magnetic Haemofiltration System in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05713188
- Acronym / sponsor ID
- MediSieve FMS study
- Conditions
- Haemofiltration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MediSieve LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Radboud University Medical Center
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Feb 2023 (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.
This is a single-centre, non-randomised, prospective study to assess the safety of the MediSieve blood filtration system in healthy volunteers
Detailed description
The MediSieve Magnetic Haemofiltration System (MMHS) is a system to filter selected moieties from blood in an extracorporeal circuit by magnetic means. Initially, it is developed for the treatment of severe malaria to capture malaria-infected erythrocytes (who are weakly magnetic) to reduce the parasitaemia. However, the use of MMHS can be extended, with the use of antibodies coupled to magnetic beads, to other diseases, such as sepsis.
The MMHS has to be used first in healthy volunteers to determine its clinical safety.
To this end, 6 healthy male and female volunteers (ratio 1:1) will undergo blood filtration using the MediSieve Magnetic Haemofiltration System (without magnetic beads) for five consecutive hours. Vital signs will be continuously monitored and blood samples will be obtained serially to determine laboratory safety and immunological parameters. Furthermore, volunteers will have two follow up visits at 24 hours and 7 days post filtration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MediSieve Magnetic Haemofiltration SystemAll volunteers will receive the same treatment |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female, ≥18 and ≤50 years of age
- Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.
Key exclusion criteria (28 listed)
- BMI <18.5 or >30 kg/m2
- Chronic medication use (except contraception)
- Pregnant or lactating females
- Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients
- History or signs of severe atopic syndrome (asthma, rhinitis with medication and/or eczema)
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 |
|---|---|---|
| MediSieve Magnetic Haemofiltration SystemThe MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream. Healthy volunteers will undergo filtration for 5 hours. | Device | Treatment |
Primary outcome
Safety (Adverse events)
Time frame: Continuously starting from 2 hours prior of the start of haemofiltration until 7 days post-filtration
Incidence of (serious) adverse events and device deficiencies during haemofiltration until 7 days post-filtration
16 secondary outcomes
Safety (Blood pressure)
Time frame: From 2 hours prior until 7 hours after start of haemofiltration.
Safety (Heart rate)
Time frame: Continuously from 2 hours prior until 7 hours after start of haemofiltration.
Safety (Temperature)
Time frame: Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.
Safety (Symptoms)
Time frame: Every 30 minutes from 2 hours prior until 7 hours after start of haemofiltration.
Safety (Immunology)
Time frame: Samples will be obtained from 1 hour prior until 7 days after start of haemofiltration.
Safety (Metal analysis)
Time frame: Samples will be obtained from start of haemofiltration, and after 1 hour, 5 hours, 24 hours and 7 days.
Safety (Cell counts)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Haemoglobin and elektrolytes)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Haematocrit)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Coagulation)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (INR)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Fibrinogen + albumin)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Kidney function)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Markers associated with cellular damage)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (C-reactive protein)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
Safety (Creatinine and iron status)
Time frame: Samples will be obtained from 2 hours prior until 7 days after start of haemofiltration.
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 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Haemofiltration
Not yet recruiting
Pharmacokinetic Profiles of Subcutaneous Enoxaparin for Thromboprophylaxis in Critically Ill Patients With Renal Failure Treated or Not With Continuous Veno-veinous Hemofiltration.
Thromboprophylaxis, Critical Illness
Not yet recruiting
The Impact of Nafamostat Mesylate on the Prognosis of Patients With Sepsis-Induced Coagulopathy Undergoing Hemofiltration
Sepsis-induced Coagulopathy (SIC)
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.
Matthijs Kox, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MediSieve Magnetic Haemofiltration System in people with Haemofiltration, run by MediSieve Limited at 1 site in Netherlands.
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 2 inclusion and 28 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 Feb 2023. 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 Netherlands. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (Adverse events) (time frame: Continuously starting from 2 hours prior of the start of haemofiltration until 7 days post-filtration). 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 Feb 2023.