H-Guard Pilot Safety Evaluation
Research type
Research Study
Full 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.
IRAS ID
322526
Contact name
Leonard Ebah
Contact email
Sponsor organisation
Invizius Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
Research Summary:
This is a first-in-human (pilot) investigation designed to assess the acute safety of H-Guard, a device solution containing a novel ancillary biologic, for use as a priming solution in the set up of haemodialysis blood tubing sets and dialysers in patients routinely undergoing dialysis. In addition to acute safety this study would explore as an exploratory measure, the potential utility of the ancillary biologic, to protect patients from inflammation arising from an immune reaction between the patients blood and dialyser using biomarkers in blood.Summary of Results:
Haemodialysis is a vital treatment for patients with severe kidney disease. It involves cleaning the blood of harmful toxins by circulating it through a special machine and then returning it to the body. However, this process can lead to heart complications, reducing both the lifespan and quality of life in some patients.A key step in haemodialysis involves preparing the machine by flushing it with a sterile liquid to ensure it is free from air bubbles, debris, and chemicals - a process known as priming.
This study investigated a new priming solution named H-Guard, designed to both prep the machine for use and protect against heart-related damage. This protection may be achieved by its binding to Factor H - a protein that helps stop the immune system from overreacting and causing harm.
This study tested how safe H-Guard is to use as a priming solution for haemodialysis kits. Its potential to make haemodialysis less stressful on the heart may improve outcomes for patients who rely on this life-saving treatment.
The researchers collected the number and seriousness of unwanted effects that patients had. An unwanted effect is considered ‘serious’ if it is life-threatening, needs hospital care, or causes lasting problems.
7 of the 8 patients (88%) had an unwanted effect during the study. None of the patients in the study had serious unwanted effects that were related to study treatment. No one died or stopped their treatment because of unwanted effects during the study.
Researchers looked at the amount of H-Guard in the body after treatment. This shows how well it gets to different parts of the body, and how the body changes and gets rid of it.
The amount of H-Guard in a patient’s blood plasma was measured. Blood plasma is the liquid part of blood that carries nutrients, proteins and blood cells. H-Guard was found in blood plasma in the initial phase of haemodialysis. The highest amounts of H-Guard were detected around three and a half hours after haemodialysis.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
23/EE/0097
Date of REC Opinion
7 Jun 2023
REC opinion
Further Information Favourable Opinion