Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulatio
- Conditions
- pediatric kidney transplant recipientsTherapeutic area: Not possible to specify
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method