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Study on Organ Preservation in Kidney, Liver, and Pancreas Transplants Using Custodiol-N Solution Compared to a Drug Combination for Transplant Patients

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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 effectiveness of two solutions used in organ transplantation, specifically for the kidney, liver, and pancreas. The trial compares a new solution called Custodiol-N with an existing solution known as Custodiol. These solutions are used to preserve organs before they are transplanted into patients. The main goal of the study is to determine if Custodiol-N is as effective as Custodiol in maintaining the function and health of the transplanted organs.

Participants in the study will be patients undergoing organ transplants. The study will involve the use of either Custodiol-N or Custodiol during the organ preservation process. The trial will monitor the function of the transplanted organs and any potential injuries that may occur after the transplantation. The study will also track various health indicators over a period of time to assess the success of the organ transplants.

The trial is designed to be prospective, meaning it will follow patients over time to observe outcomes. It is also randomized, which means participants will be randomly assigned to receive either Custodiol-N or Custodiol. The study is single-blind, so the patients will not know which solution they are receiving, but the researchers will. This approach helps ensure that the results are unbiased and reliable. The study is expected to continue until the end of 2025.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. You will be required to provide your signed informed consent before the transplantation process begins.

  2. Step 2

    Preparation for transplantation

    You will be prepared for the transplantation of a kidney, liver, or kidney-pancreas. This involves medical evaluations to ensure you meet the criteria for receiving an organ.

  3. Step 3

    Transplantation procedure

    During the transplantation, the organ will be preserved using either the Custodiol-N solution or the Custodiol solution. These solutions are used to maintain the organ's condition before it is transplanted.

  4. Step 4

    Post-transplantation monitoring

    After the transplantation, your health and the function of the transplanted organ will be closely monitored. This includes checking for any signs of delayed graft function or other complications.

    For kidney transplants, the main focus will be on the function of the kidney, including creatinine levels and the need for dialysis.

    For liver transplants, the success will be measured by monitoring liver function tests over the first 7 days and checking for any biliary complications.

    For pancreas transplants, insulin requirements and other markers will be assessed to ensure the pancreas is functioning properly.

  5. Step 5

    Follow-up assessments

    You will have follow-up assessments at various intervals, such as 3 months after the transplantation. These assessments will include blood tests and other evaluations to ensure the transplanted organ is functioning well.

    For kidney transplants, creatinine levels, urea, and hemoglobin will be checked.

    For liver transplants, liver function tests and bilirubin levels will be monitored.

    For pancreas transplants, insulin requirements and other markers like C-peptide and HBA1c will be evaluated.

Who can join the trial?

7 criteria

  • Patients who are going to have a kidney, liver, or kidney-pancreas transplant.
  • Donors must be deceased adults (18 years or older) who meet the criteria for organ donation.
  • For living kidney donations, donors must be adults (18 years or older) who meet the criteria for organ donation.
  • Recipients must be waiting for their transplant.
  • Recipients must be 18 years or older.
  • Recipients must provide signed informed consent before the transplantation. This means they agree to participate in the study after being informed about it.
  • For liver transplants, the recipient must be receiving a full organ transplant.

Who cannot join the trial?

1 criterion

  • Patients who are going to have a **kidney**, **liver**, or **kidney-pancreas** transplant cannot participate.
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Investigated drugs

  • Custodiol-N

    is a special solution used to protect organs like the kidney, liver, and pancreas when they are being transplanted. It helps keep the organs healthy and working well while they are outside the body, waiting to be placed into the recipient. This solution is designed to reduce any damage to the organs during this time, making sure they function properly once transplanted.

  • Custodiol

    is another solution used for preserving organs during transplantation. Like Custodiol-N, it helps maintain the health and function of organs such as the kidney, liver, and pancreas while they are outside the body. The goal is to minimize any harm to the organs during the transplant process, ensuring they work effectively after being transplanted.

What is already known about the treatment

Custodiol-N – Custodiol-N is a solution used in organ transplantation to preserve organs like the kidney, liver, and pancreas before they are transplanted into a patient. It is administered by flushing the organ with the solution to keep it viable until transplantation. Currently, Custodiol-N is being studied in clinical trials to compare its effectiveness with another solution called Custodiol. The main goal is to ensure that Custodiol-N is not inferior in preserving organ function and reducing injury after transplantation. This solution is part of the pharmacological class of organ preservation solutions, which are crucial in maintaining the health of organs outside the body.

Investigated diseases

  • Kidney Transplantation

    Kidney transplantation involves replacing a diseased kidney with a healthy one from a donor. After transplantation, the new kidney takes over the function of filtering waste from the blood. Initially, there may be a period of delayed graft function, where the kidney does not work immediately. Over time, the kidney may experience primary poor function, which is characterized by high creatinine levels. Patients may require dialysis if the kidney does not function adequately. Rejection of the kidney can occur, which is when the body's immune system attacks the new organ.

  • Liver Transplantation

    Liver transplantation is the process of replacing a failing liver with a healthy one from a donor. After the procedure, the liver's function is monitored through various blood tests, including GPT and LDH levels. The liver may experience complications such as cholestasis, where bile flow is reduced or blocked. Biliary complications can also occur, including cholangitis, biliary leakage, and strictures. The success of the transplant is often evaluated by the liver's ability to produce proteins and process bilirubin. Over time, the liver should resume normal function, but complications can arise that require medical attention.

  • Pancreas Transplantation

    Pancreas transplantation involves replacing a diseased pancreas with a healthy one from a donor. The new pancreas should help regulate blood sugar levels by producing insulin. Initially, insulin requirements are monitored to assess the function of the transplanted pancreas. Complications can include graft pancreatitis, where the pancreas becomes inflamed, and anastomotic leaks, where connections between the pancreas and other organs leak. Vascular complications such as thrombosis, stenosis, and bleeding can also occur. Over time, the pancreas should help maintain normal blood sugar levels, reducing the need for insulin therapy.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512444-29-00Estimated enrolment362 patientsSponsorDr. Franz Koehler Chemie GmbH

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