RecruitingPHASE3INTERVENTIONAL

Efficacy and Safety of XyloCore Peritoneal Dialysis Solution.

This important study is testing a new type of fluid, called XyloCore, used in a home dialysis treatment called peritoneal dialysis. We're looking for adults in the UK with serious kidney disease who are already on this type of dialysis. The study aims to see if XyloCore is safe and works as well as, or better than, the usual dialysis fluids that contain glucose. Participants will either continue with their current dialysis fluids or switch to XyloCore for a six-month period. This research is vital to find new and potentially better ways to help people manage their kidney condition from home, aiming to improve their health and daily lives.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Iperboreal Pharma Srl

Enrolment target

170

Start

14 Dec 2022

Estimated completion

28 Apr 2027

End Stage Renal Disease

What is this study about?

This study is about a new type of special fluid called XyloCore, which is used in a home dialysis treatment called 'peritoneal dialysis' (sometimes called CAPD). Peritoneal dialysis helps clean your blood when your kidneys are no longer working properly. This treatment involves putting a special fluid into your tummy through a small tube. This fluid then soaks up waste products from your body before being drained out. The new fluid, XyloCore, has a different make-up from the fluids currently used.

At the moment, most peritoneal dialysis fluids contain glucose (a type of sugar). While these work well, there's always an interest in finding new fluids that might have different benefits, perhaps by being gentler on the body in the long run. This study wants to see if XyloCore is just as safe and effective as the glucose-based fluids that are widely used today. It's a 'Phase 3' study, which means it's one of the final steps before a new treatment might become more generally available.

You might be wondering why this study matters. For people living with End-Stage Renal Disease (ESRD), managing their condition and finding the best possible treatments to keep them healthy and comfortable is crucial. If XyloCore proves to be a good option, it could offer another choice for people on peritoneal dialysis, potentially leading to better long-term outcomes and a good quality of life. This research is about exploring new options to help people live well with kidney disease.

Key takeaways

This study is testing a new peritoneal dialysis fluid called XyloCore.
It's for adults in the UK with serious kidney disease on home dialysis.
The study lasts for six months, involving regular check-ups.
Participants will either use XyloCore or continue with their usual fluid.
The aim is to find safer and more effective dialysis options.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been receiving peritoneal dialysis (CAPD) for your serious kidney disease for at least the last three months. It's important that your general health has been stable during this time, meaning no recent hospital stays for unexpected reasons or major heart problems. You also shouldn't have had any serious infections in the last three months, including infections related to your dialysis.

You should also be using a specific type of dialysis fluid called Extraneal for your overnight dialysis exchange, and one of several other common fluids for your daytime exchanges. Your doctors will be able to tell you if your current dialysis plan fits this. Your kidneys' cleaning effectiveness (measured by something called Kt/V urea) also needs to be at a certain level at the start of the study.

There are also some reasons why you wouldn't be able to join. For example, if you've had issues with drug or alcohol use recently, have certain liver problems, or have an active infection, you wouldn't be able to take part. Women who are pregnant, breastfeeding, or of childbearing age not using reliable contraception also cannot participate. Your doctor will carefully check all these details to see if this study is suitable and safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been on peritoneal dialysis for at least 3 months for serious kidney disease?
Have you been generally stable and healthy in the last 3 months (no major hospital stays)?
Are you currently using Extraneal for your overnight dialysis and certain other fluids for daytime?
Are you not pregnant or breastfeeding, and for women, using reliable contraception if of childbearing age?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) into one of two groups: one will continue with your usual dialysis fluids, and the other will switch to the new XyloCore fluid for your daytime exchanges. Everyone in the study will continue using Extraneal for their overnight dialysis.

The study will last for six months. During this time, you'll continue your peritoneal dialysis at home as usual. Your doctors will monitor your health closely and might adjust the strength of your dialysis fluid or the number of daily exchanges if needed, to make sure you're getting the right treatment. You'll have regular hospital visits for check-ups, blood tests, and to make sure your dialysis is working effectively. These visits are important for your safety and to collect information for the study. The doctors and nurses caring for you will know which fluid you are using, but the team checking the results will not know, to keep things fair.

Potential risks and benefits

Taking part in a study like this can have potential benefits. You'll receive very careful and regular monitoring of your health by a specialist team, and you might be among the first to try a new dialysis fluid that could offer different benefits. However, there are also potential risks, as with any medical treatment. The new fluid might not work as well for you as your current one, or you might experience side effects, although the study team will be looking out for these very carefully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Aalborg University
Verified postcode
Aalborg, Denmark· Not yet recruiting
Aarhus University Hospital
Verified postcode
Aarhus, Denmark· Recruiting
Zealand University Hospital
Verified postcode
Roskilde, Denmark· Recruiting
Dialysis Center DaVita
Verified postcode
Düsseldorf, Germany· Recruiting
Ospedale Madonna del Soccorso
Verified postcode
Ascoli Piceno, Italy· Recruiting
Ospedale Santa Maria Annunziata
Verified postcode
Bagno a Ripoli, Italy· Not yet recruiting
Azienda Universitaria Ospedaliera di Bari
Verified postcode
Bari, Italy· Recruiting
ASST Spedali Civili di Brescia
Verified postcode
Brescia, Italy· Not yet recruiting
Ospedale SS. Annunziata
Verified postcode
Chieti, Italy· Recruiting
IRCCS Policlinico San Martino
Verified postcode
Genova, Italy· Not yet recruiting
Ospedale Civile San Salvatore
Verified postcode
L’Aquila, Italy· Recruiting
ASST Fatebenefratelli-Sacco -Ospedale Luigi Sacco
Verified postcode
Milan, Italy· Recruiting

Common questions

What is peritoneal dialysis?

It's a way to clean your blood at home using a special fluid passed into your tummy through a tube, removing waste products when your kidneys can't.

What is XyloCore?

XyloCore is a new type of fluid for peritoneal dialysis that is being tested to see if it's safe and effective, potentially offering an alternative to current glucose-based fluids.

How long will the study last?

If you join, you will be part of the study for six months, with regular check-ups during this time.

Will I have to pay for anything?

No, all study-related treatments, tests, and visits are covered by the study and you will not have to pay.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, without needing to give a reason, and it won't affect your ongoing medical care.

How to find out more

Arduino Arduini, MD

a.arduini@iperboreal.com +39.333.6409595 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.