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

UMIN ID: UMIN000001649

Registered date:31/01/2014

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Adult Recipients after liver transplantation
• Date of first enrollment: 2009/01/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Area under the blood concentration time curve Clinical Response
• Secondary Outcome: Clinical Response Incidence of Adverse Event A change of tacrolimus blood trough level A change of tacrolimus blood peak level Drug compliance

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Graduate School of Medicine, Osaka University Department of Surgery
• Source(s) of Monetary Support: Astellas Pharma Inc.