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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the study

    You begin the trial as a person who has started incremental haemodialysis, which means dialysis is done less than 3 times per week.

    You receive Ketosteril, an oral coated tablet. The dose is 50 units by mouth. The treatment is given as an add-on to the usual nutritional plan.

    The trial is designed to follow the period of incremental haemodialysis and to measure how long this period lasts.

  2. Step 2

    During treatment

    You continue the study treatment with Ketosteril by mouth at a dose of 50 units. The source information does not specify a different frequency or a fixed end date for this medicine.

    Your incremental haemodialysis period continues while the study records its duration in months.

    The study also records whether dialysis is reduced for palliative and end-of-life care. This type of dialysis reduction is not counted in the main study measure.

  3. Step 3

    Scheduled study checks

    At the start of treatment and then every 3 months, you complete checks of quality of life, perceived diet quality, and appetite.

    WHO QoL means a questionnaire about quality of life from the World Health Organization.

    MDRD diet quality questionnaire means a questionnaire about how good your diet is.

    CNAQ means the Council on Nutrition Appetite Questionnaire, which asks about appetite.

  4. Step 4

    Nutritional and clinical follow-up

    The study checks your nutritional status using blood tests and body measurements.

    The recorded items include albumin, hemoglobin, CRP, and pre-albumin. CRP means a blood marker that can show inflammation.

    The study also records whether you need ESAs, which are medicines that help the body make red blood cells.

    Your weight, BMI (body mass index, a measure based on height and weight), body composition by bioimpedance (a test that estimates body water and body makeup), and handgrip strength are measured.

    The study also uses SGA and MIS. SGA means a general nutrition assessment. MIS means a score used to assess nutrition and health status.

  5. Step 5

    Outcome recording during the trial

    The study records whether you are alive or have died during the trial period.

    It records hospitalizations for any cause, except the hospital stay at the start of dialysis and hospital care for end-of-life treatment.

    It records the combined outcome of death and hospitalization.

    It also records costs related to incremental haemodialysis and Ketosteril, compared with standard haemodialysis.

    It records sustainability outcomes, including savings in water, energy, and waste because of fewer dialysis sessions.

  6. Step 6

    End of the study follow-up

    Your participation continues until the study ends or until the incremental haemodialysis period is no longer being followed for the trial outcome.

    The main result is the duration in months of the incremental haemodialysis period.

    The trial is planned to run from 2026-03-01 to 2030-03-01.

Who can join the trial?

3 criteria

  • 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 trial?

12 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Ketosteril - Ketosteril is an oral coated tablet taken by mouth, usually swallowed with water, and it is used as a nutritional support medicine in people with long-term kidney disease who need to limit protein intake. It is still used in medical practice and is discussed in medical literature as a supportive treatment, especially for patients with reduced kidney function or during dialysis planning. Its main use is to help provide essential building blocks for body proteins while lowering the amount of nitrogen waste made by the body; it contains amino acids and keto analogues that the body can convert into useful amino acids, and it is classified as an amino acid combination supplement.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524093-41-00Estimated enrolment70 patients

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).