Wednesday 7 February 2024

The first patient has been recruited to a new device study which aims to improve dialysis treatment by preventing side effects for kidney disease patients.

The National Institute for Health and Care Research (NIHR) Manchester Clinical Research Facility (CRF) at Manchester Royal Infirmary (MRI) is the only UK site to deliver the Phase 1 trial and a total of 10 patients will be enrolled in this study.

The investigation will assess the effectiveness of ‘H-Guard’ – a new priming solution which could be used during the set-up of the dialysis machines for patients routinely undergoing dialysis.

Kidneys usually filter and remove waste products from the blood. Haemodialysis, the most common type of dialysis, replaces some kidney functions for people with kidney failure, by using a machine to filter and clean blood. During dialysis, blood passes along a tube and into an external machine that filters it before it is passed back into the arm along another tube.

Study Co-Investigator and Renal Registrar Dr Duha Ilyas, from MRI, which is part of Manchester University NHS Foundation Trust (MFT), said;

“Many patients receiving dialysis treatment suffer from inflammation and unpleasant side effects. This can be caused by an immune reaction when blood comes into contact with the dialysis circuit.

“This research study will look at using a new priming solution, which will be flushed through the circuit before starting dialysis treatment, which aims to reduce the patient’s immune reaction during dialysis and hopefully prevent side effects. If successful, it could become a normal part of dialysis treatment.”

The first patient

Cora Nolan, 57, from Wythenshawe, Manchester, (pictured) was the first person to take part in the study. She’s been receiving dialysis treatment 3 times a week at Manchester Royal Infirmary for the last 2 years.

Cora, who has type 1 diabetes, said;

“When I was first asked if I wanted to take part in this research study, I just thought ‘you never know, it might help someone in the future’ and I wanted to give it a go.”

First patient Cora Nolan pictured with (from L-R) Reethu Chacko (Renal Research Nurse), Dr Duha Ilyas (Study Co-investigator and Renal Registrar), Ramil Biaddang (Acute Kidney Unit Nurse) and Ginu Varghese (NIHR Manchester CRF at MRI Deputy Nurse Manager).

Cora, who has 3 daughters and 7 grandchildren, had to stop working as a mortgage advisor due to starting dialysis treatment. She added;

“I wanted to feel as if I was doing something that might make a difference, something positive, and the staff at the Manchester CRF were all absolutely fantastic.”

Dialysis technology has become more advanced in recent years but side effects can still occur.

Dr Ilyas (pictured above with Cora) explains further;

“When the patient’s blood goes into the dialysis circuit, it comes into contact with a foreign surface which has the ability to cause activation of the immune system. By coating these components of the dialysis system with the novel H-Guard solution, the immune reaction and therefore subsequent inflammation is reduced.

“This Phase 1 clinical trial is looking at the safety of using H-Guard in patients on dialysis who are vulnerable to this persistent immune activation. There is a wealth of evidence that demonstrates persistent inflammation has consequences which include an increased risk of heart and vascular disease, conditions that commonly affect our dialysis patients.”

Principal Investigator on the study, Dr Leonard Ebah who is also a Consultant Nephrologist and Medical Director at MRI, said:

“Excess inflammation has been linked to the primary causes of premature death in patients on dialysis. This approach aims to tackle this and eventually improve patient outcomes.”

Each participant on the study will undergo one haemodialysis treatment specifically at the Manchester CRF at the MRI. The team is aiming to complete the trial within the next 4 months.