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Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation
EU CTIS ID: 2024-511585-36-00
What this study is testing
The key objective is to personalize tacrolimus treatment for children with a renal transplant by using dosing algorithms to calculate both the individual’s tacrolimus starting dose and follow-up doses.
- Therapeutic use (Phase IV)
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
- Age 2-18 years old
- Patients to be transplanted with a kidney allograft
- Patients receiving a kidney from a blood group ABO-compatible donor
- Patients who will receive tacrolimus as part of their initial immunosuppressive therapy
- Signed written informed consent.
You likely can't join if
- Recipients of a non-renal organ transplant at the same occasion
- Recipients of a blood group ABO-incompatible kidney allograft
- Recipients of an HLA-incompatible kidney allograft (positive cross-match)
- Recipients receiving tacrolimus as immunosuppressive treatment within the preceding 28 days.
- Recipients using medication known to have a pharmacokinetic (drug-drug) interaction with tacrolimus (see Appendix I, table 1 for specification).
- Extra exclusion criteria for participation in study part B: Children who are not able to swallow a once-daily tacrolimus capsule
See the full eligibility criteria
- Age 2-18 years old
- Patients to be transplanted with a kidney allograft
- Patients receiving a kidney from a blood group ABO-compatible donor
- Patients who will receive tacrolimus as part of their initial immunosuppressive therapy
- Signed written informed consent.
- Recipients of a non-renal organ transplant at the same occasion
- Recipients of a blood group ABO-incompatible kidney allograft
- Recipients of an HLA-incompatible kidney allograft (positive cross-match)
- Recipients receiving tacrolimus as immunosuppressive treatment within the preceding 28 days.
- Recipients using medication known to have a pharmacokinetic (drug-drug) interaction with tacrolimus (see Appendix I, table 1 for specification).
- Extra exclusion criteria for participation in study part B: Children who are not able to swallow a once-daily tacrolimus capsule
- Extra exclusion criteria for participation in study part B: Children with changes in the administration of drugs interacting with tacrolimus around the switch to the once-daily formulation.
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.
Explore other conditions
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.