Ketosteril Added to Usual Nutrition for Patients Starting Incremental Haemodialysis with Incremental Haemodialysis

2 1 1 1

What is this study about?

This study is being done in people with Incremental Haemodialysis, a form of dialysis in which treatment is started at a lower number of sessions each week and may be increased later if needed. The treatment being studied is Ketosteril, a tablet that contains several amino acids and related substances that help support the body’s protein needs. The purpose of the study is to see whether adding Ketosteril to the usual diet plan can help people stay longer on the lower-frequency dialysis schedule.

People in the study will receive Ketosteril together with their usual nutritional care, and their course will be followed over time. The study will compare how long the lower-frequency dialysis period lasts and will also look at general health, hospital stays, survival, eating and nutrition, and overall quality of life. The study is exploratory, which means it is intended to learn more about whether this approach may be useful.

During the study, health checks and routine follow-up will be done at regular visits. Information about dialysis sessions, diet, and general well-being will be collected to understand how the treatment works in everyday care.

Who Can Join the Study?

  • Adults, meaning people who are 18 years old or older.
  • Willing and able to give informed consent, which means they understand the study and agree to take part by signing the required form.
  • Just starting incremental haemodialysis, which means beginning a type of dialysis treatment that starts with fewer or lighter sessions and may increase over time.

Who Cannot Join the Study?

  • Refusing to give informed consent, which means not agreeing to take part after the study has been explained.
  • Having already taken part in a randomized study using Ketosteril, meaning a study where treatment is assigned by chance.
  • Being currently included in another interventional clinical trial, which is a study that gives a treatment or procedure to test its effect.
  • Being under legal protection, such as being a person under guardianship, a minor, a prisoner, or a pregnant or breastfeeding woman.
  • Having acute kidney injury (a sudden loss of kidney function).
  • Having a life expectancy of less than 3 months, or having a kidney transplant planned within the next 3 months.
  • Having cognitive impairment severe enough to prevent understanding the study or agreeing to take part, meaning serious problems with thinking, memory, or understanding.
  • Having a condition that makes kidney function impossible to recover, such as both kidneys having been removed or complete and permanent destruction of kidney tissue.
  • Having a genetic disease that affects amino acid metabolism, meaning the body cannot process certain building blocks of proteins normally.
  • Having hypercalcemia, meaning calcium in the blood is above the normal range, and this has lasted for at least one month.
  • Having an allergy or other hypersensitivity to Ketosteril or to any of its ingredients.
  • Not following the prescribed dialysis plan, meaning not complying with the kidney cleaning treatment schedule.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier Le Mans Le Mans France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.03.2026

Trial locations

Ketosteril is an oral coated tablet used as an add-on treatment in this trial. It contains a mix of amino acid precursors that help the body make needed proteins while reducing the amount of nitrogen waste that has to be processed. In this study, it is being added to the usual nutrition plan for people starting incremental hemodialysis to see whether it can help them stay on the lower dialysis schedule for a longer time.

Investigated diseases:

Incremental Haemodialysis – Incremental haemodialysis is a form of kidney replacement therapy in which dialysis is started at a lower frequency than the usual three sessions per week. It is used in people whose remaining kidney function still helps clear fluid and waste, so the dialysis schedule can begin more gradually. Over time, the need for dialysis may increase as kidney function declines and the body can no longer maintain balance as well. The course is typically marked by a stepwise move toward more frequent dialysis sessions when kidney function worsens.

Trial ID:
2025-524093-41-00
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study comparing medium-chain triglycerides and sodium chloride infusions during hemodialysis to improve toxin removal in patients with chronic kidney disease

    Recruiting

    2 1 1 1
    France
  • Study on Rivaroxaban for Patients with End-Stage Renal Disease on Hemodialysis

    Recruiting

    2 1 1 1
    Investigated drugs:
    France