Ended Therapeutic exploratory (Phase II) Prophylaxis of primary liver, kidney, heart, lung, and intestinal organ transplant rejection

A trial to compare the levels of the active ingredient tacrolimus in the blood of patients before and after switching between the Prograf and Advagraf formulations including a longer follow-up of the effectiveness and safety of Advagraf.

EU CTIS ID: 2024-513546-11-00

What this study is testing

To compare the steady state AUC0-24h of tacrolimus for Advagraf® with that of Prograf® in stable pediatric allograft recipients after 1:1 (mg:mg) conversion from Prograf® to Advagraf®.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The subject is at least 5 years and not older than 16 years of age, inclusive.
  • The subject must be able to swallow intact study medication capsules.
  • The subject received a single solid organ transplant at least 6 months prior to entry into the study.
  • The subject’s parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable.
  • The subject has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
  • Female subjects of child bearing potential must provide a negative urine or serum pregnancy test prior to enrolment in the study

You likely can't join if

  • The subject has previously received a multiple organ transplant.
  • The subject has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator.
  • The subject is participating or has participated in another clinical trial and/or is taking or has taken an investigational/non-registered drug in the past 28 days.
  • The subject is unlikely to comply with the visits scheduled in the protocol.
  • The subject has experienced any rejection episode within 3 months prior to enrolment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months.
  • The subject is currently receiving Rapamycin, Certican or MPA (Myfortic®).
See the full eligibility criteria
Who can join
  • The subject is at least 5 years and not older than 16 years of age, inclusive.
  • The subject must be able to swallow intact study medication capsules.
  • The subject received a single solid organ transplant at least 6 months prior to entry into the study.
  • The subject’s parent(s), or their legal representative(s), has been fully informed and has given written informed consent to participate in the study. The subject has given assent where applicable.
  • The subject has been receiving a Prograf® based immunosuppressive regimen for a minimum of 3 months
  • Female subjects of child bearing potential must provide a negative urine or serum pregnancy test prior to enrolment in the study
  • Male and female subjects that are sexually active must agree to practice effective birth control during the study. (An effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner).
  • Additional Inclusion Criterion on Day 1: Subject has stable whole blood trough levels of tacrolimus in the range of 3.5-15 ng/mL measured on at least 2 separate occasions taken at least 6 days apart within 30 days prior to Day 1 and is clinically stable in the opinion of the Investigator.
What rules you out
  • The subject has previously received a multiple organ transplant.
  • The subject has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator.
  • The subject is participating or has participated in another clinical trial and/or is taking or has taken an investigational/non-registered drug in the past 28 days.
  • The subject is unlikely to comply with the visits scheduled in the protocol.
  • The subject has experienced any rejection episode within 3 months prior to enrolment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy, or 2 or more rejection episodes within the last 12 months.
  • The subject is currently receiving Rapamycin, Certican or MPA (Myfortic®).
  • The subject has a chronic dysfunction of the allograft, in the opinion of the Investigator.
  • The subject had major changes in their immunosuppressive regimen within the last 3 months prior to entry into the study.
  • The subject has any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator.
  • The subject is known to be positive for either HBV or HCV or HIV.
  • The subjects is required to be treated with medication or substances known to interfere with tacrolimus metabolism as listed in Appendix 1, or having taken such medication within 28 days prior to inclusion.
  • The subject is pregnant or breast feeding.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.