A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted from a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow Up

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513546-11-00

Acronym

PMR-EC-1206

Enrollment

Registered

2024-06-28

Start date

2014-03-10

Completion date

2025-11-03

Last updated

2025-06-12

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

Conditions

Prophylaxis of primary liver, kidney, heart, lung, and intestinal organ transplant rejection

Brief summary

The steady state systemic exposure (AUC0-24h) of tacrolimus when administered as Advagraf® or Prograf® in stable pediatric allograft recipients.

Detailed description

Secondary pharmacokinetic variables: Cmax; tmax; C24, Safety: Incidence of adverse events; Laboratory parameters; Vital signs, Efficacy: Rejection episodes; Subject and graft survival

Interventions

DRUGAdvagraf 0.5 mg prolonged-release hard capsules

DRUGAdvagraf 1 mg prolonged-release hard capsules

DRUGAdvagraf 5 mg prolonged-release hard capsules

DRUGAdvagraf 3 mg prolonged-release hard capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The steady state systemic exposure (AUC0-24h) of tacrolimus when administered as Advagraf® or Prograf® in stable pediatric allograft recipients.	—

Secondary

Measure	Time frame
Secondary pharmacokinetic variables: Cmax; tmax; C24, Safety: Incidence of adverse events; Laboratory parameters; Vital signs, Efficacy: Rejection episodes; Subject and graft survival	—

Countries

Czechia

Outcome results

None listed

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