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Study on Mannitol and Normal Saline for Patients with End-Stage Renal Disease Undergoing Kidney Transplantation

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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment for patients with end-stage renal disease who are undergoing kidney transplantation. The study will compare the use of a solution called mannitol with normal saline in individuals who have received a kidney from a brain-dead donor. The main goal is to determine if mannitol can help improve the success of kidney transplants by reducing a condition known as delayed graft function, which is when the new kidney takes longer than expected to start working properly.

Participants in the study will receive either mannitol or a placebo, which is a substance with no active treatment, through an intravenous infusion. The study will monitor how quickly the transplanted kidney begins to function and will also look at other factors such as the occurrence of acute kidney graft rejection within three months and the kidney's performance at different time points, including seven days, one month, and three months after the transplant.

The trial aims to provide valuable information on whether mannitol can be a beneficial treatment option for improving outcomes in kidney transplant patients. The study will be conducted over a period of time, with participants being closely monitored to assess the effectiveness and safety of the treatment. This research could potentially lead to better management strategies for patients undergoing kidney transplantation, ultimately improving their quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose, which is to determine if mannitol can improve kidney transplant outcomes by reducing delayed graft function.

    You will be randomly assigned to receive either mannitol or a placebo, which is a substance with no active medication, to compare the effects.

  2. Step 2

    Receiving treatment

    The treatment involves receiving mannitol or a placebo through an intravenous route, meaning it will be administered directly into your vein.

    The dosage, frequency, and duration of administration will be determined by the study protocol and communicated to you by the medical team.

  3. Step 3

    Monitoring and follow-up

    Your kidney function will be closely monitored throughout the trial. This includes measuring the time it takes for your kidney to start working properly after the transplant.

    Additional assessments will be conducted to check for any signs of delayed kidney graft function, acute rejection of the kidney, and to estimate kidney function at 7 days, 1 month, and 3 months after the transplant.

  4. Step 4

    Completion of the trial

    The trial is expected to continue until the end of 2048, but your participation will be limited to the duration necessary to gather the required data.

    Upon completion, the results will be analyzed to determine the effectiveness of mannitol in improving kidney transplant outcomes.

Who can join the trial?

4 criteria

  • Patients must be receiving a kidney allograft, which means a kidney transplant from another person.
  • The kidney must come from an adult brain-dead donor, which means the donor is an adult who has been declared brain-dead.
  • Patients of all genders are eligible to participate.
  • Patients must be within the age range of 18 to 64 years old.

Who cannot join the trial?

3 criteria

  • Patients with **end-stage renal disease** who have not undergone a **kidney transplantation** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population cannot participate.
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Investigated drugs

  • Mannitol

    is a type of sugar alcohol that is used in medical settings to help reduce swelling and pressure inside the brain. In this clinical trial, it is being tested to see if it can improve the outcomes of kidney transplants. The researchers want to find out if mannitol can help the new kidney start working faster after the transplant, which is known as reducing delayed graft function. This means that mannitol might help the kidney function better and sooner after it has been transplanted into the recipient.

  • Normal Saline

    is a sterile mixture of salt and water that is commonly used in medical treatments. It is often used to hydrate patients or to deliver medications through an IV. In this trial, normal saline is being used as a comparison to mannitol. The researchers want to see if mannitol is more effective than normal saline in helping the new kidney start working properly after a transplant. Normal saline serves as a standard treatment to compare the effects of mannitol against.

What is already known about the treatment

Mannitol – Mannitol is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials to see if it can help improve kidney transplant outcomes by reducing a complication known as delayed graft function. This medication is primarily used in medical settings to help reduce pressure in the brain and eyes, and in this trial, it is being explored for its potential benefits in kidney transplantation. Mannitol works by drawing water out of tissues and into the blood, which can help reduce swelling and improve blood flow. It is classified as an osmotic diuretic, which means it helps the body remove excess water and salt.

Investigated diseases

  • End-stage renal disease

    This condition occurs when the kidneys are no longer able to function at a level needed for day-to-day life. It is the final stage of chronic kidney disease, where the kidneys have lost about 90% of their ability to work normally. As the disease progresses, waste products and excess fluid build up in the body, leading to symptoms such as fatigue, swelling, and difficulty concentrating. Patients may experience a decrease in urine output and an increase in blood pressure. Without functioning kidneys, the body cannot maintain a balance of fluids, electrolytes, and waste products. This condition requires interventions to replace the lost kidney function.

  • Kidney transplantation

    This is a surgical procedure to place a healthy kidney from a donor into a person whose kidneys no longer function properly. The transplanted kidney takes over the work of the two failed kidneys, filtering waste and excess fluids from the blood. Over time, the body may recognize the new kidney as foreign, which can lead to immune responses and potential rejection. The progression of this condition involves monitoring for signs of rejection and ensuring the transplanted kidney is functioning well. The success of the transplant can be affected by factors such as delayed graft function, where the new kidney does not start working immediately. Regular follow-up is necessary to assess kidney function and manage any complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518817-24-01Estimated enrolment466 patientsSponsorHUS-yhtymae

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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).