2024-511585-36-00
Not yet recruiting
Phase 4
Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)2 sites in 1 country28 target enrollmentStarted: June 28, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- 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
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 0 years to 17 years (0-17 Years)
- Accepts Healthy Volunteers
- No
Inclusion 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
- •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.
Outcomes
Primary Outcomes
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
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 Outcomes
No secondary outcomes reported
Investigators
Huib de Jong
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Study Sites (2)
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