The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation

The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation - The evaluation of efficacy and safety in modification to new immunosuppressant (tacrolimus hydrate:Graceptor) from the current immunosuppressive therapy after liver transplantation

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000001649

Enrollment

Registered

2014-01-31

Start date

2009-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Adult Recipients after liver transplantation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Adults recipients after liver transplantation 2 The recipients who agree to this study 3 more than 6 months after liver transplantation 4 clinicopathologically diagnosed with well functioning

Exclusion criteria

Exclusion criteria: 1 clinicopathologically diagnosed with rejection in recent 90 days . 2 underwent rejection treatment in recent 6 months 3 diagnosed with rejection beyond twice in 12 months 4 liver dysfunction ,AST>=40, or ALT>=40 5 Drug user of cross interaction with Tacrolimus 6 Other severe concomitant disease or medical conditions. 7 drug abuser, mentally unstable recipient, The patient who was judged to have difficulty in communication with the doctor 8 History of contraindication to tacrolimus. 9 A pregnant woman or a woman with possibility becoming pregnant 10 severe renal dysfunction 11 Inappropriate patients for entry on this trial in the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
Area under the blood concentration time curve Clinical Response	—

Secondary

Measure	Time frame
Clinical Response Incidence of Adverse Event A change of tacrolimus blood trough level A change of tacrolimus blood peak level Drug compliance	—

Countries

Japan

Contacts

Public ContactShigeru Marubashi, MD., PhD

Graduate School of Medicine, Osaka University Department of Surgery

smarubashi@gesurg.med.osaka-u.ac.jp06-6879-3251

Outcome results