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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Failure
- Sponsor
- Invizius Limited
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] when using H-Guard as a Priming Solution
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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. 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 1. Screening \[up to 30 days prior to the start of the clinical trial\] 2. A non-interventional haemodialysis using standard priming solutions \[Baseline - mid-week session: Day 0\] 3. For WoCBP - a serum hCG test will be repeated between days 1-6 prior to intervention 4. A single haemodialysis using H-Guard to first prime the dialyser and tubing set \[mid-week session: Day 7\] 5. Followed by a further non-interventional haemodialysis without H-Guard \[i.e. using standard priming solutions\] \[first haemodialysis post intervention\] 6. A follow up visit 7 days post intervention to perform antibody analysis 7. Finally a follow up visit 14-21 days post intervention to perform antibody analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
- •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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Assess the Presence of AOT Antibody Analysis 14-21 days Post Intervention(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)(Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10))
- Assess the Presence of AOT Antibody Analysis 7 days Post Intervention(Assessed at visit 6 (day 14) [7 days after H-Guard intervention])
- Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (CRP)(Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10))
- Measure of Dialysis Adequacy via Urea and Beta-2-Microglobulin Biomarkers(Assessed at visit 4 (day 7) [H-Guard priming] and visit 5 (day 10))
- Changes in Biomarker Analysis (Coag) Prior to and Post Intervention (wbc count)(Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10))
- Changes in Biomarker Analysis (Infl) Prior to and Post Intervention (albumin)(Assessed at visits screening, visit 4 (day 7) and visit 5 (day 10))
- Analysis of Plasma AOT Proteins post intervention(Assessed at visit 4 (day 7) [H-Guard priming])