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

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on patients with chronic hemodialysis who have been receiving treatment for more than 3 months and have no remaining urine production. The study aims to test a new method to improve the removal of harmful substances from the blood during dialysis treatment. The main focus is on improving the removal of a substance called p-cresyl sulfate, which is typically difficult to remove during regular dialysis sessions.

The study will compare two different approaches during dialysis sessions: one using Medialipide, which is a special fat-based solution containing medium-chain triglycerides and soya oil, and another using standard sodium chloride solution (salt water). Each dialysis session in the study will last for 4 hours, during which these solutions will be given through an intravenous line.

During the treatment, researchers will measure how effectively the dialysis removes various harmful substances from the blood. They will also monitor the safety of using Medialipide by checking for side effects such as nausea, vomiting, headaches, and by measuring blood levels of fats and liver function. Blood samples will be taken at different times during the dialysis session to measure the levels of various substances.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial hemodialysis session

    You will undergo a standard hemodialysis session lasting 4 hours

    During this session, you will receive an infusion of either Medialipide (a fatty acid solution) or saline solution

    Blood samples will be taken from the dialysis machine at the start of the session

  2. Step 2

    Monitoring during session

    Throughout the 4-hour session, medical staff will collect samples from your blood and dialysis fluid

    Your condition will be monitored for any signs of discomfort such as nausea, vomiting, or headache

  3. Step 3

    End of session measurements

    At the end of the 4-hour session, final blood samples will be taken

    Your triglyceride levels (fat levels in blood) will be measured

    Additional blood tests will check your liver function

  4. Step 4

    Follow-up session

    After a period of time, you will undergo a second 4-hour dialysis session

    This session will be identical to the first, but with the alternative solution (either Medialipide or saline)

    The same measurements and monitoring will be performed as in the first session

  5. Step 5

    Final assessment

    Your blood test results will be analyzed to measure the effectiveness of both treatment methods

    The medical team will evaluate how well different waste products were removed from your blood during each session

Who can join the trial?

10 criteria

  • Must be 18 years or older
  • Must be receiving hemodialysis treatment (a procedure that filters waste and excess fluid from blood) three times per week, with each session lasting 4 hours, for at least 3 months
  • Must have no residual urine production (less than 100 mL per day)
  • For women who can become pregnant:
    • Must use highly effective contraception throughout the study duration
    • Acceptable methods include:
      • Complete sexual abstinence
      • Combined hormonal contraception
      • Bilateral tubal ligation (surgical blocking of fallopian tubes)
      • Must undergo a pregnancy blood test (beta-HCG) when joining the study
      • Must be enrolled in a social security program
      • Must be able to provide written informed consent to participate in the study

Who cannot join the trial?

10 criteria

  • Patients who have been on hemodialysis for less than 3 months
  • Patients who have residual urine output more than 100 mL per day (residual diuresis - remaining ability to produce urine)
  • Children and adolescents under 18 years of age
  • Pregnant or breastfeeding women
  • Patients with known allergies to medium-chain fatty acids (type of fats used in the study medication)
  • Patients who cannot provide informed consent
  • Patients participating in other clinical trials
  • Patients with severe heart, liver, or blood disorders
  • Patients with active infections
  • Patients with unstable medical conditions that could interfere with the study procedures
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Investigated drugs

  • Medialipide

    is a medium-chain fatty acid emulsion used during hemodialysis treatment. It is administered through infusion during dialysis sessions to help improve the removal of harmful toxins from the blood, particularly substances called protein-bound uremic toxins. This medication works by helping to separate these toxins from proteins in the blood, making them easier to remove during the dialysis process.

  • Saline

    is a sterile solution of salt water that is commonly used in medical procedures. In this trial, it serves as a comparison treatment, being infused during hemodialysis sessions to compare its effectiveness against Medialipide in removing toxins from the blood.

What is already known about the treatment

Medialipide – A medium-chain fatty acid emulsion administered through intravenous infusion during hemodialysis treatment. This medication is being studied in clinical trials for its potential to enhance the removal of protein-bound uremic toxins, particularly p-cresyl sulfate, in patients undergoing chronic hemodialysis. The mechanism of action involves the fatty acids competing with uremic toxins for protein binding sites in the blood, potentially making these toxins more available for removal during dialysis. Medialipide belongs to the class of lipid emulsions used in clinical nutrition and is being investigated for this novel application in nephrology to improve dialysis efficiency.

Investigated diseases

End-Stage Renal Disease with Chronic Hemodialysis Dependence - A condition where the kidneys have permanently lost their ability to function, requiring regular hemodialysis treatments to filter waste products from the blood. This condition develops when kidney function deteriorates to the point where natural filtration becomes insufficient, leading to the accumulation of toxins and waste products in the blood. In this specific state, patients produce virtually no urine (less than 100mL per day) and have been receiving dialysis for more than 3 months. The body cannot maintain proper fluid and electrolyte balance without external support, and various uremic toxins, including p-cresyl sulfate and indoxyl sulfate, build up between dialysis sessions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510406-41-00Protocol code69HCL23_0031Estimated enrolment12 patientsSponsorHospices Civils De Lyon

sourced from the EU Clinical Trials Register and site verification

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