AuthorisedTherapeutic exploratory (Phase II)Interventional

INCREDIBLE: INCREmental DIalysis and diet for a Better Life Experience; Clinical relevance of an “add-on” Ketosteril supplementation on incremental haemodialysis period in incident haemodialysis patients. An exploratory randomized controlled trial

This research, called INCREDIBLE, is looking at a specific type of kidney dialysis called incremental haemodialysis. This means having dialysis less often than the usual three times a week. The study wants to see if adding a medicine called Ketosteril to a patient's routine can help them stay on this less frequent dialysis for longer. Researchers will also be checking how this affects their quality of life, hospital visits, and overall health. The aim is to find ways for people with kidney disease to live better lives while managing their condition. It's an early-stage study, designed to explore these ideas safely.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Le Mans

Enrolment target

Start

18 May 2026

Incremental Haemodialysis

What is this study about?

When your kidneys aren't working well enough, you might need dialysis to help clean your blood. Often, people start with dialysis three times a week. However, some people might be able to begin with 'incremental' haemodialysis, meaning they have it less often than that, perhaps twice a week. This study is exploring if a particular medicine, Ketosteril, along with advice on diet, can help people stay on this less frequent dialysis for a longer time.

The main aim is to see how many months people can continue with the less frequent dialysis when they take Ketosteril. This could be a good thing because having dialysis less often can mean more time for your normal activities and a better quality of life. The study will also look at how this treatment affects important things like how often people need to go to the hospital, their general health, how they feel day-to-day, and if it saves money or resources.

This is an 'exploratory' study, which means it's an earlier stage of research. The purpose is to gather information and see if this approach is promising enough to investigate further in larger studies. It's about finding better ways to manage kidney disease and improve the lives of people who need dialysis.

Key takeaways

This study explores a medicine (Ketosteril) for people on less frequent kidney dialysis.
The goal is to help people stay on incremental dialysis for longer, improving quality of life.
Researchers will check health, well-being, and hospital visits.
It's an early-stage study, aiming to find better ways to manage kidney disease.
Participation involves regular check-ups and questionnaires.

Who may be eligible?

To be part of this study, you would need to be an adult, aged 18 or over. The study is open to both men and women.

The most important factor is that you have just started or are about to start a specific type of kidney dialysis called 'incremental haemodialysis'. This means you are on a schedule where you have dialysis less than three times a week. However, this study is not for people who are having less frequent dialysis as part of end-of-life care.

Quick self-check

Are you 18 years old or older?
Have you recently started or are you about to start kidney dialysis?
Is your dialysis schedule less than three times a week (incremental dialysis)?
Are you NOT having less frequent dialysis as part of end-of-life care?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you would be randomly assigned to either receive the usual care or to receive the medicine Ketosteril in addition to your dialysis. You would continue with your current incremental haemodialysis schedule. Over time, usually every three months, the researchers would check in with you. These check-ups would involve questionnaires about your quality of life and diet, as well as several health measurements like your weight, blood tests, and handgrip strength. The total length of your participation would depend on how long you remain on incremental dialysis.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit of this study could be that taking Ketosteril helps you stay on incremental dialysis for longer, potentially leading to a better quality of life. However, like all medicines, Ketosteril can have side effects, and these would be explained to you in detail by the study team. You would receive regular medical care throughout the study. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
France

Common questions

What is 'incremental haemodialysis'?

It means having kidney dialysis less often than the usual three times a week, often at the start of treatment.

What is Ketosteril?

It's a medication that might help people on dialysis. The study is looking into its effects.

Will I definitely get Ketosteril if I join?

No, participants are randomly assigned to either receive Ketosteril or standard care, like flipping a coin.

How long will the study last for me?

Your involvement would last as long as you are successfully on incremental haemodialysis, with regular check-ups every three months.

Will my regular kidney care be affected?

No, you will continue to receive all your usual and necessary medical care for your kidney condition.