Renal FailureNCT06070337
H-Guard Pilot Safety Evaluation in Haemodialysis Patients
A study testing H-Guard in people with Renal Failure and Renal Insufficiency, run by Invizius Limited at 1 site in United Kingdom.
Trial summary
The purpose of this research study is to find out the safety and effectiveness of a new medical device called H-Guard. During this research study, participants will receive the standard of care haemodialysis treatment, as decided by the treating doctor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Renal Insufficiency, Renal Disease
- What is being tested?
- H-Guard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Oct 2023to 29 Feb 2024
- 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 subjects aged 18 years and older at screening who have provided a signed and dated written informed consent
- Stable haemodialysis patients who are undergoing centre-based maintenance haemodialysis due to advanced kidney disease CKD stage 5, via arterio-venous fistula, graft or central venous catheter (i.e. with or without permanent vascular access)
- C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates
- Cytokine release assay - IL-6 concentrations following H-Guard vs Human Serum Albumin exposure must not exceed >50% and absence of significant Human Serum Albumin stimulated reactivity
- Willing and able to attend and comply with study visits and study related activities
Who cannot join
- Patients requiring haemodialysis for acute kidney injury on critical care (ITU)
- Patients unable or unwilling to comply with all trial procedures, e.g. blood sampling
- Patients with a likely survival prognosis of less than 6 months
- Patients who have been admitted for any acute hospital-based treatments in the last 6 weeks
- Patients on any medication which may interfere with the analysis of the biomarkers
- Current or history of use of anti-thrombotic therapy less than 7 days prior to screening.
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- Currently active malignancy
- Currently receiving radiation, immunotherapy or chemotherapy
- Patients with active infection or receiving antibiotics within 30 days prior to screening
- Currently enrolled or has been enrolled in the last 30 days in another investigational device or drug study
- Known allergy or hypersensitivity to any component of the study device and/or medication to be used during the study.
- Patients lacking capacity to provide informed consent
- Pregnant or breastfeeding women
- Women of child-bearing potential (WoCBP)* who are unwilling to practice highly effective contraception or undergo pregnancy tests at screening and during the study*
- Positive HIV and hepatitis B and C status, assessed from medical records only
- Patients with haematology or biochemistry results out of the normal reference range for this indication, assessed from medical records using test results obtained within 30 days of screening visit Any patients who are not deemed suitable for the study, as per the investigator's clinical opinion.
- Pregnancy testing and contraception are not required for women not of child-bearing potential, including postmenopausal women or those with documented hysterectomy or bilateral oophorectomy. Postmenopausal women must be amenorrhoeic for at least 12 months in order not to be considered of childbearing potential. When postmenopausal status is uncertain, this will be confirmed by measurement of FSH.
- Highly effective contraceptive measures include stable use of combined (oestrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal ligation; vasectomized partner; and sexual abstinence***.
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL
About this study
Official title: A Within-patient, Pilot Assessment of the Safety and Performance of H-Guard as a Priming Solution for Use in the Set-up of Blood Tubing Sets and Dialysers Prior to Use in Haemodialysis Patients
The purpose of this research study is to find out the safety and effectiveness of a new medical device called H-Guard.
During this research study, participants will receive the standard of care haemodialysis treatment, as decided by the treating doctor. Participants will be observed during 5-6 haemodialysis treatments throughout the course of the study. The only change to the treatment process, will be the use of the medical device (H-Guard) to prime the dialysis system, before one of the treatments.
Participants will have various blood tests taken throughout the course of the study for safety and research analysis.
Read the detailed description
This prospective, open-label, study will be conducted in accordance with the requirements of EN ISO 14155, the Declaration of Helsinki (revised version of Edinburgh, Scotland 2000), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and the current national regulations and guidelines, approved by both the local ethics committee and regulatory authority.
The study will be performed in a stable participant population who are on haemodialysis and who have a blood biomarker profile at screening, suggesting an increased risk of sensitivity to the haemodialysis dialyser and/or blood tubing sets (C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates). Participants will be recruited based on participation in a prior screening study and will attend a total of six-seven consecutive visits during the clinical trial
- Screening [up to 30 days prior to the start of the clinical trial]
- A non-interventional haemodialysis using standard priming solutions [Baseline - mid-week session: Day 0]
- For WoCBP - a serum hCG test will be repeated between days 1-6 prior to intervention
- A single haemodialysis using H-Guard to first prime the dialyser and tubing set [mid-week session: Day 7]
- Followed by a further non-interventional haemodialysis without H-Guard [i.e. using standard priming solutions] [first haemodialysis post intervention]
- A follow up visit 7 days post intervention to perform antibody analysis
- Finally a follow up visit 14-21 days post intervention to perform antibody analysis.
- Conditions
- Renal Failure, Renal Insufficiency, Renal Disease
- Being tested
- H-Guard
- Keywords
- Renal Failure, Haemodialysis, Renal, Kidney Failure, Dialysis
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-GuardDevice
A novel Haemodialyser primer used for one treatment only
| Study group | Role | What they receive |
|---|---|---|
| H-Guard | Experimental | Participants receiving H-Guard Intervention. Receives: Device: H-Guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] when using H-Guard as a Priming Solution
Review of Adverse Events and Serious Adverse Event Frequency (All assessments)
Measured: Assessed from date of consent until the end of the study (day 28)
Secondary outcomes (8)
Assess the Presence of AOT Antibody Analysis 7 days Post Intervention
Antibodies will be measured as ng/ml serum
Measured: Assessed at visit 6 (day 14) [7 days after H-Guard intervention]
Assess the Presence of AOT Antibody Analysis 14-21 days Post Intervention
Antibodies will be measured as ng/ml serum
Measured: Assessed at visit 7 (day 21-28) [14-21 days after H-Guard intervention]
Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (platelet count)
Biomarkers of coagulation - Platelet count
Measured: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (wbc count)
Biomarkers of coagulation - WBC count
Measured: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (CRP)
Biomarkers of inflammation - CRP in mg/L
Measured: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (albumin)
Biomarkers of inflammation - albumin in g/L
Measured: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Analysis of Plasma AOT Proteins post intervention
Pharmacokinetic analysis of peak concentration in plasma (ng/ml plasma)
Measured: Assessed at visit 4 (day 7) [H-Guard priming]
Measure of Dialysis Adequacy via Urea and Beta-2-Microglobulin Biomarkers
To assess dialysis adequacy pre- and immediately post haemodialysis (H-Guard priming) (Urea and Beta 2 Microglobulin)
Measured: Assessed at visit 4 (day 7) [H-Guard priming] and visit 5 (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start19 Oct 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, open label, pilot study of H-Guard® administered as a priming solution to both the blood tubing sets and dialyser of patients who are undergoing haemodialysis.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invizius Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tailored Clinical Research Solutions (TCRS)
- Responsible party
- Sponsor
- Investigators
- Leonard Ebah, Principal investigator, Manchester University NHS Foundation TrustMagnus Nicolson, Study director, Invizius Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070337
- Sponsor's protocol ID
- IH_001
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be kept confidential and used only for the purpose of this study or future research about the device under investigation.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Within-patient, Pilot Assessment of the Safety and Performance of H-Guard as a Priming Solution for Use in the Set-up of Blood Tubing Sets and Dialysers Prior to Use in Haemodialysis Patients
- ClinicalTrials.gov ID
- NCT06070337
- Acronym / sponsor ID
- IH_001
- Conditions
- Renal Failure, Renal Insufficiency, Renal Disease
- Keywords
- Renal Failure, Haemodialysis, Renal, Kidney Failure, Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Invizius LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Tailored Clinical Research Solutions (TCRS)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 6 Oct 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.
The purpose of this research study is to find out the safety and effectiveness of a new medical device called H-Guard.
During this research study, participants will receive the standard of care haemodialysis treatment, as decided by the treating doctor. Participants will be observed during 5-6 haemodialysis treatments throughout the course of the study. The only change to the treatment process, will be the use of the medical device (H-Guard) to prime the dialysis system, before one of the treatments.
Participants will have various blood tests taken throughout the course of the study for safety and research analysis.
Detailed description
This prospective, open-label, study will be conducted in accordance with the requirements of EN ISO 14155, the Declaration of Helsinki (revised version of Edinburgh, Scotland 2000), Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and the current national regulations and guidelines, approved by both the local ethics committee and regulatory authority.
The study will be performed in a stable participant population who are on haemodialysis and who have a blood biomarker profile at screening, suggesting an increased risk of sensitivity to the haemodialysis dialyser and/or blood tubing sets (C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates). Participants will be recruited based on participation in a prior screening study and will attend a total of six-seven consecutive visits during the clinical trial
- Screening [up to 30 days prior to the start of the clinical trial]
- A non-interventional haemodialysis using standard priming solutions [Baseline - mid-week session: Day 0]
- For WoCBP - a serum hCG test will be repeated between days 1-6 prior to intervention
- A single haemodialysis using H-Guard to first prime the dialyser and tubing set [mid-week session: Day 7]
- Followed by a further non-interventional haemodialysis without H-Guard [i.e. using standard priming solutions] [first haemodialysis post intervention]
- A follow up visit 7 days post intervention to perform antibody analysis
- Finally a follow up visit 14-21 days post intervention to perform antibody analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, open label, pilot study of H-Guard® administered as a priming solution to both the blood tubing sets and dialyser of patients who are undergoing haemodialysis.
| Arm | Type | Receives |
|---|---|---|
| H-Guard | Experimental | Device: H-GuardParticipants receiving H-Guard Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects aged 18 years and older at screening who have provided a signed and dated written informed consent
- Stable haemodialysis patients who are undergoing centre-based maintenance haemodialysis due to advanced kidney disease CKD stage 5, via arterio-venous fistula, graft or central venous catheter (i.e. with or without permanent vascular access)
- C3 deposition assay ratio ≤0.3 - measured immunologically using a C3 antibody in H-Guard vs human serum albumin coated ELISA plates
- Cytokine release assay - IL-6 concentrations following H-Guard vs Human Serum Albumin exposure must not exceed >50% and absence of significant Human Serum Albumin stimulated reactivity
- Willing and able to attend and comply with study visits and study related activities
Key exclusion criteria (19 listed)
- Patients requiring haemodialysis for acute kidney injury on critical care (ITU)
- Patients unable or unwilling to comply with all trial procedures, e.g. blood sampling
- Patients with a likely survival prognosis of less than 6 months
- Patients who have been admitted for any acute hospital-based treatments in the last 6 weeks
- Patients on any medication which may interfere with the analysis of the biomarkers
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 |
|---|---|---|
| H-GuardA novel Haemodialyser primer used for one treatment only | Device | H-Guard |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] when using H-Guard as a Priming Solution
Time frame: Assessed from date of consent until the end of the study (day 28)
Review of Adverse Events and Serious Adverse Event Frequency (All assessments)
8 secondary outcomes
Assess the Presence of AOT Antibody Analysis 7 days Post Intervention
Time frame: Assessed at visit 6 (day 14) [7 days after H-Guard intervention]
Assess the Presence of AOT Antibody Analysis 14-21 days Post Intervention
Time frame: Assessed at visit 7 (day 21-28) [14-21 days after H-Guard intervention]
Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (platelet count)
Time frame: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (wbc count)
Time frame: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (CRP)
Time frame: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (albumin)
Time frame: Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10)
Analysis of Plasma AOT Proteins post intervention
Time frame: Assessed at visit 4 (day 7) [H-Guard priming]
Measure of Dialysis Adequacy via Urea and Beta-2-Microglobulin Biomarkers
Time frame: Assessed at visit 4 (day 7) [H-Guard priming] and visit 5 (day 10)
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 7 Mar 2024.
- Individual participant dataSharing planned: No. All data will be kept confidential and used only for the purpose of this study or future research about the device under investigation.
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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.
Leonard Ebah principal investigator
Manchester University NHS Foundation Trust
Magnus Nicolson study director
Invizius Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-Guard in people with Renal Failure and Renal Insufficiency, run by Invizius Limited at 1 site in United Kingdom.
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 5 inclusion and 19 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 7 Mar 2024. 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 United Kingdom. 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 Treatment-Emergent Adverse Events [Safety and Tolerability] when using H-Guard as a Priming Solution (time frame: Assessed from date of consent until the end of the study (day 28)). 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 7 Mar 2024.