niertransplantatie immunosuppressant drugs renal transplantation
Conditions
Interventions
All participants will receive a tacrolimus starting dose based on a dosing
algorithm which takes bodyweight and genetic factors into account, rather than
the standard dose which is based on bodyweig
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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 Extra exclusion criteria for participation in study part B: - Children who are not able to swallow a once-daily tacrolimus capsule - Children with changes in the administration of drugs interacting with tacrolimus around the switch to the once-daily formulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of children within the target C0 range of tacrolimus (10-15 ng/mL) on day 3 after kidney transplantation following algorithm-based dosing | — |
Secondary
| Measure | Time frame |
|---|---|
| • The percentage of patients with markedly supra- (> 20 ng/L) or sub- ( | — |
Countries
Netherlands
Outcome results
None listed