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Study Comparing Tacrolimus Levels in Children with Organ Transplants Switching from Prograf to Advagraf

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 is focused on studying the effects of the medication tacrolimus in children who have received an organ transplant, such as a liver, kidney, heart, lung, or intestine. The study involves switching patients from a medication called Prograf to a different formulation called Advagraf, which is a prolonged-release capsule. The purpose of the study is to compare the levels of tacrolimus in the blood before and after the switch to ensure the new formulation is safe and effective.

Participants in the study will take the Advagraf capsules orally, which means they will swallow them. The study will monitor the levels of tacrolimus in the blood over time to see how the body processes the medication. This will help determine if the new formulation maintains the necessary levels of the drug to prevent the body from rejecting the transplanted organ. The study will also keep track of any side effects or adverse events that may occur during the treatment period.

The study will include a long-term follow-up to assess the safety and effectiveness of Advagraf over an extended period. This means that participants will be observed for any changes in their health or any episodes of organ rejection. The goal is to ensure that the new formulation provides the same benefits as the previous one while being safe for long-term use in children who have undergone organ transplants.

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 participant must be between 5 and 16 years old and have received a single organ transplant at least 6 months prior.
The participant must be able to swallow the study medication capsules whole and have been on a Prograf-based treatment for at least 3 months.
A negative pregnancy test is required for female participants of childbearing potential, and effective birth control must be practiced by sexually active participants.
Step 2
Initial assessment
The participant's blood levels of tacrolimus must be stable, within the range of 3.5-15 ng/mL, measured on at least two occasions at least 6 days apart within 30 days before the study begins.
The participant must be clinically stable as determined by the investigator.
Step 3
Medication conversion
The participant will switch from a Prograf-based regimen to an Advagraf-based regimen, maintaining the same dosage in milligrams.
Advagraf is taken orally as prolonged-release capsules, available in 0.5 mg, 1 mg, 3 mg, and 5 mg doses.
Step 4
Monitoring and follow-up
The study will monitor the levels of tacrolimus in the participant's blood to compare the effects of Advagraf and Prograf.
The study will also track any side effects, laboratory results, vital signs, and any episodes of organ rejection.
The participant's and the transplanted organ's survival will be evaluated throughout the study.
Step 5
Long-term follow-up
The study includes a long-term follow-up to assess the effectiveness and safety of the Advagraf regimen.
The estimated end date for the study is May 31, 2026.

Who can join the trial?

8 criteria

The child must be at least 5 years old and not older than 16 years.
The child must be able to swallow whole capsules of the study medication.
The child must have received a single organ transplant, such as a liver, kidney, heart, lung, or intestine, at least 6 months before joining the study.
The child's parent(s) or legal representative(s) must be fully informed and must give written consent for the child to participate in the study. The child must also agree to participate if applicable.
The child must have been taking a medication called **Prograf®**, which helps prevent organ rejection, for at least 3 months.
If the child is a girl who can become pregnant, she must have a negative pregnancy test before joining the study.
If the child is sexually active, they must agree to use effective birth control during the study. Effective birth control methods include implants, injections, birth control pills, certain devices placed in the uterus, not having sex, or having a partner who has had a vasectomy.
On the first day of the study, the child must have stable levels of a medication called **tacrolimus** in their blood, measured on at least two different occasions at least 6 days apart within the 30 days before the study starts. The child must also be considered clinically stable by the doctor in charge of the study.

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Fakultni nemocnice Motol a Homolka
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Prague, Czechia

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Investigated drugs

Prograf
is a medication used to prevent the body from rejecting a transplanted organ. It is part of an immunosuppressive regimen, which means it helps to suppress the immune system to prevent it from attacking the new organ. In this study, patients who are stable on Prograf are being switched to another form of the medication to see how their bodies process it.
Advagraf
is another form of the medication tacrolimus, similar to Prograf, but it is designed to be released slowly over time. This study is examining how the body absorbs and processes Advagraf compared to Prograf in children who have received organ transplants. The goal is to see if Advagraf can be a suitable alternative to Prograf for maintaining the health of the transplanted organ.

Tacrolimus

What is already known about the treatment

Tacrolimus – Tacrolimus is an immunosuppressive medication primarily used to prevent organ transplant rejection, including liver, kidney, heart, lung, and intestinal transplants. It is administered orally in the form of capsules or tablets. The medication is currently well-established in medical practice and literature, with ongoing studies to optimize its use in pediatric patients. Tacrolimus works by inhibiting calcineurin, a protein involved in activating T-cells, which are part of the immune response. This action helps to suppress the immune system and prevent it from attacking the transplanted organ. Tacrolimus is classified as a calcineurin inhibitor in pharmacology.

Investigated diseases

Organ Transplant Rejection – This condition occurs when the immune system of a person who has received an organ transplant attacks the new organ, mistaking it for a harmful invader. The immune response can lead to inflammation and damage to the transplanted organ. Rejection can be acute, happening soon after the transplant, or chronic, developing over a longer period. Symptoms may include fever, pain at the transplant site, and changes in organ function. The progression of rejection can vary, with some cases being mild and others more severe. Monitoring and managing the immune response is crucial to prevent damage to the transplanted organ.