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A multicentre, 1:1 randomised, double blind, two arm parallel group study to evaluate and compare the efficacy and safety of modified release tacrolimus FK506E (MR4) versus tacrolimus FK506 in combination with steroid in patients undergoing primary liver transplantation.

A multicentre, 1:1 randomised, double blind, two arm parallel group study to evaluate and compare the efficacy and safety of modified release tacrolimus FK506E (MR4) versus tacrolimus FK506 in combination with steroid in patients undergoing primary liver transplantation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000306-46-IT
Enrollment
Unknown
Registered
2004-09-01
Start date
2004-07-16
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Liver transplantation

Interventions

Trade Name: Tacrolimus Product Name: modified release tacrolimus Product Code: FK506E (MR4) Pharmaceutical Form: Current Sponsor code: FG-506E-11-03 Concentration unit: mg milligram(s) Concentratio

Sponsors

FUJISAWA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Finland, Italy, Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026