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A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation (MAIN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339468
First Posted: April 20, 2011
Last Update Posted: July 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.

Condition Intervention Phase
Liver Transplantation Drug: Advagraf Drug: Prograf Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration [ Time Frame: Day 6 and day 21 ]

Secondary Outcome Measures:
  • Cmax (maximum concentration) of tacrolimus plasma concentration [ Time Frame: Day 6 and day 21 ]
  • Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) [ Time Frame: up to 24 weeks ]
  • Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR) [ Time Frame: up to 24 weeks ]
  • Safety assessed by the incidence of adverse events and lab-tests [ Time Frame: up to 24 weeks ]

Enrollment: 100
Actual Study Start Date: April 27, 2011
Study Completion Date: May 27, 2014
Primary Completion Date: May 27, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Intravenous Prograf therapy followed by oral Advagraf therapy
Drug: Advagraf
oral
Other Names:
  • FK506E
  • modified release tacrolimus
Drug: Prograf
intravenous
Other Names:
  • tacrolimus
  • FK506
Active Comparator: Arm 2
Intravenous Prograf therapy followed by oral Prograf therapy
Drug: Prograf
oral
Other Names:
  • FK506
  • tacrolimus
Drug: Prograf
intravenous
Other Names:
  • tacrolimus
  • FK506

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject receiving a primary, partial liver graft from a living donor
  • subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined

Exclusion Criteria:

  • subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
  • subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
  • subjects allergic or intolerant to macrolide antibiotics or tacrolimus
  • subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
  • subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
  • subjects with systemic infection requiring treatment, except viral hepatitis
  • subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
  • subjects with serum creatinine > 1.5mg/dl
  • subjects taking or having taken potassium preserved diuretics
  • subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
  • subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days
  • subjects or donors known to be HIV positive
  • donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339468


Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01339468     History of Changes
Other Study ID Numbers: MR-08-04-KOR_Main
First Submitted: April 12, 2011
First Posted: April 20, 2011
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Astellas Pharma Inc:
advagraf
prograf
living donor liver transplantation
FK506
Immunosuppressant

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action