Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511585-36-00

Enrollment

Registered

2024-06-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-28

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

Conditions

pediatric kidney transplant recipients

Brief summary

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

Interventions

DRUG5 mg capsule

DRUGEnvarsus 4 mg prolonged-release tablets

DRUGEnvarsus 1 mg prolonged-release tablets

DRUGPROGRAF 5 mg capsule

DRUGPROGRAF 1 mg capsule

DRUGModigraf 0.2 mg granules for oral suspension

DRUGEnvarsus 0.75 mg prolonged-release tablets

DRUGPROGRAF 0

DRUGModigraf 1 mg granules for oral suspension

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

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	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026