Genotype-informed dosing of tacrolimus for children after organ transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how tailoring tacrolimus dosage based on genetic makeup can optimize drug exposure in pediatric solid organ transplant recipients. By using Bayesian modeling to predict drug levels, the researchers aim to achieve therapeutic drug concentrations while minimizing adverse events. Participants will undergo genotyping for CYP3A4 and CYP3A5 enzymes to guide tacrolimus dosing before and after transplantation. The goal is to improve treatment outcomes and reduce the risk of acute rejection associated with improper drug levels.

Why it matters

Who can join: the full rules

Participants will be assigned to the prospective arm if treated at Royal Children's Hospital who are receiving a solid organ transplant (SOT) (excluding repeat graft in liver transplant recipients, or lung or intestinal transplant) and who will be on tacrolimus as one of the main immunosuppressants post-transplant.

Inclusion Criteria:

* Age 1-18 years of age
* Kidney, liver or heart transplant recipients
* Participant and/or parent consent to the study (prospective arm only)

Exclusion Criteria:

* Previous liver transplant.
* Lung OR Intestinal transplant.
* Insufficient time before transplant for pharmacogenomic analysis (prospective arm only)
* Immunosuppressant regimen not containing tacrolimus immediate release product
* Known hypersensitivity to tacrolimus and/or its formulation.

Where it's running

• Royal Children's Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Rachel Conyers — Murdoch Childrens Research Institute
• Study coordinator: Rachel Conyers
• Email: pharmaco.genomics@mcri.edu.au
• Phone: 03 9936 6770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• A tablet game to help kids with solid organ transplants remember and learn their medicines

  A tablet-based educational game is being tested to see if it helps kids aged 7–17 on solid organ transplants learn about their meds and stay adherent.

  Recruiting Stanford University · Palo Alto, California · NCT07609303

• Virtual mentorship program for parents of pediatric organ transplant recipients

  This study tests whether a virtual mentorship program can help parents of children who have had organ transplants feel less alone and improve their mental health.

  Recruiting The Hospital for Sick Children · Toronto, Ontario · NCT05968807

• Understanding respiratory viral infections in pediatric transplant recipients

  This study is trying to see if measuring respiratory viruses before a transplant can help predict which kids might get respiratory infections afterward.

  Recruiting at 27 sites Arkansas Children's Hospital Research Institute · Birmingham, Alabama and 26 other locations · NCT05550298

• Delayed infusion of a naïve T cell–depleted hematopoietic graft with memory T cells for solid organ transplant recipients

  This early study will test whether giving a donor-derived stem cell graft that’s depleted of naïve T cells but includes memory T cells can safely help children and adults who receive kidney, lung, or multivisceral transplants tolerate the new organ with less long-term immune-suppressing medicine.

  Recruiting Phase 1 Hospital Universitario La Paz · Madrid, Madrid · NCT06997471

• Transplanting gut bacteria to improve outcomes in organ transplant patients

  This study tests whether transplanting gut bacteria can help organ transplant patients who are having stomach issues feel better and reduce complications.

  Recruiting The Second Hospital of Nanjing Medical University · Nanjing, Jiangsu · NCT06730451

• Treatment for Epstein-Barr Virus-Associated Lymphoproliferative Disease After Transplant

  This study is testing a new treatment called tabelecleucel for patients with a specific type of cancer related to Epstein-Barr virus who haven't improved with other therapies after receiving a transplant.

  Recruiting at 35 sites Phase 3 Pierre Fabre Medicament · Duarte, California and 70 other locations · NCT03394365

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.