Avoiding tacrolimus under- and overexposure by using a new dosing algorithm for pediatric renal transplant recipients

Avoiding tacrolimus under- and overexposure by using a new dosing algorithm for pediatric renal transplant recipients - Tacrolimus starting dose in children based on an algorithm

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44606

Enrollment

Registered

2017-08-10

Start date

2017-11-21

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Voorkomen afstoting na niertransplantatie kidney transplantation

Interventions

All participants will receive the tacrolimus starting dose based on a dosing algorithm which bases the dose on bodyweight, CYP3A5 genotype and donor type, rather than the standard bodyweight-based d

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: * Age 2-18 years old * Patients receiving a kidney from a blood group AB0-compatible donor * Patients who will receive tacrolimus as part of the initial immunosuppressive therapy * Signed written informed consent

Exclusion criteria

Exclusion criteria: * Recipients of a non-renal organ transplant at the same occasion * Recipients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days. * Recipients using medication known to have a relevant pharmacokinetic interaction with tacrolimus

Design outcomes

Primary

Measure	Time frame
The main study parameter is the percentage of children within the target C0 range of tacrolimus on day 3, 7 and 10 after kidney transplantation.	—

Secondary

Measure	Time frame
Secondary study endpoints of the study are: * The proportion of patients with markedly supra- (>20 ng/mL) or sub-therapeutic (	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)