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Personalized Tacrolimus Treatment for Children with Kidney Transplants Using a Dosing Algorithm

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 children who have received a kidney transplant. The study is investigating the use of a medication called tacrolimus, which is commonly used to help prevent the body from rejecting a new kidney. The trial aims to personalize the treatment for each child by using a special method to calculate the right dose of tacrolimus for them. This method involves a dosing algorithm, which is a type of formula that helps doctors decide how much medication a child should take.

In this study, children will receive one of several forms of tacrolimus, including PROGRAF capsules, Modigraf granules for oral suspension, and Envarsus prolonged-release tablets. These medications are all taken by mouth. The goal is to find the best way to give tacrolimus so that it works effectively and safely for each child. The study will monitor how well the children maintain the right levels of tacrolimus in their blood, especially in the first few days after their kidney transplant.

The purpose of the study is to improve the way tacrolimus is given to children who have had a kidney transplant, making it more tailored to their individual needs. This approach hopes to ensure that each child receives the most effective dose with the least risk of side effects. The study will last for a period of time, during which the children will be closely observed to see how well the personalized dosing works for them.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient is required to meet specific criteria, including being between the ages of 2 and 18, receiving a kidney transplant from a compatible donor, and having signed informed consent.
Step 2
Initial treatment phase
The patient begins treatment with tacrolimus, a medication used to prevent organ rejection. The initial dose is calculated using a personalized dosing algorithm.
The medication is administered orally in various forms, such as capsules, oral suspension, or prolonged-release tablets. The specific form and dosage depend on the patient's needs.
Step 3
Medication administration
The patient receives tacrolimus in one of the following forms: PROGRAF 1 mg capsule, Modigraf 0.2 mg granules for oral suspension, Envarsus 0.75 mg prolonged-release tablets, PROGRAF 0.5 mg capsule, Envarsus 4 mg prolonged-release tablets, Envarsus 1 mg prolonged-release tablets, PROGRAF 5 mg capsule, or Modigraf 1 mg granules for oral suspension.
The medication is taken once daily, and the dosage is adjusted based on the patient's response and blood levels of the drug.
Step 4
Monitoring and adjustments
The patient's blood levels of tacrolimus are monitored to ensure they remain within the target range of 10-15 ng/mL by day 3 after transplantation.
Adjustments to the dosage are made as needed, based on the results of these tests and the patient's overall health.
Step 5
Follow-up and evaluation
The patient continues to receive regular follow-up care to monitor the effectiveness of the treatment and to make any necessary adjustments to the medication regimen.
The study aims to personalize the treatment to achieve the best possible outcomes for each patient.

Who can join the trial?

5 criteria

Age between 2 and 18 years old.
Must be scheduled to receive a kidney transplant.
Receiving a kidney from a donor with a compatible blood type. **ABO-compatible** means the blood types of the donor and recipient match or are compatible.
Will be taking **tacrolimus** as part of the initial treatment to prevent the body from rejecting the new kidney. **Tacrolimus** is a medication that helps the body accept the new organ.
Must have signed a written informed consent. This means agreeing to participate in the study after understanding all the details and risks involved.

Who cannot join the trial?

3 criteria

Patients who are not children with a kidney transplant cannot participate.
Patients who are younger than 2 years old cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

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Verified sites

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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Stichting Radboud University Medical Center
Responsive
Nijmegen, The Netherlands

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Investigated drugs

Tacrolimus is a medication used to help prevent the body from rejecting a transplanted kidney. In this clinical trial, the focus is on personalizing the treatment for children who have received a kidney transplant. The trial uses a dosing algorithm to determine the best starting dose and follow-up doses for each child, aiming to improve the effectiveness and safety of the treatment.

Tacrolimus

What is already known about the treatment

Tacrolimus – Tacrolimus is administered orally in the form of capsules or as an extended-release formulation, taken once daily. It is currently well-established in medical practice and literature, particularly for use in organ transplant patients to prevent rejection. The main therapeutic indication for tacrolimus is to help prevent organ rejection in pediatric kidney transplant recipients. At the molecular level, tacrolimus works by inhibiting calcineurin, a protein involved in activating T-cells, which are part of the immune system. This action suppresses the immune response, reducing the risk of transplant rejection. Tacrolimus is classified as an immunosuppressant medication.

Investigated diseases

Pediatric Kidney Transplant Recipients – This condition involves children who have received a kidney transplant due to kidney failure or severe kidney disease. After the transplant, the child's body may recognize the new kidney as foreign and attempt to reject it. To prevent this, medications like tacrolimus are used to suppress the immune system. The progression of this condition involves careful monitoring and adjustment of medication to ensure the transplanted kidney functions properly. Over time, the child's body may adapt to the new kidney, but ongoing medical supervision is necessary. The focus is on maintaining the health of the transplanted kidney and preventing rejection.