MedTrace Logo

Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®

NCT01294020 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-12-08

No results posted yet for this study

Summary

Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.

Part C: Continuation of long-term follow-up and provision of ongoing study medication to subjects to whom Advagraf® is currently not available.

Conditions

  • Intestine Transplantation
  • Kidney Transplantation
  • Lung Transplantation
  • Liver Transplantation
  • Heart Transplantation

Interventions

DRUG

Tacrolimus

Oral capsule

DRUG

Tacrolimus prolonged release

Oral capsule

Sponsors & Collaborators

  • Astellas Pharma Europe Ltd.

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Astellas Pharma Europe Ltd.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-25
Primary Completion
2015-10-25
Completion
2025-11-03

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01294020 on ClinicalTrials.gov