NCT06070337

H-Guard Pilot Safety Evaluation in Haemodialysis Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Invizius Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure
• Renal Insufficiency
• Renal Disease

Interventions

Type	Name	Description
DEVICE	H-Guard	A novel Haemodialyser primer used for one treatment only

Timeline

• Start date: 2023-10-19
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2023-10-06
• Last updated: 2024-03-07

Locations

1 site across 1 country: United Kingdom