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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 is currently recruiting participants.
Verified October 2012 by Astellas Pharma Inc
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01339468
First received: April 12, 2011
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum concentration) of tacrolimus plasma concentration [ Time Frame: Day 6 and day 21 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse events and lab-tests [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 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:
  • FK506
  • tacrolimus
Active Comparator: Arm 2
Intravenous Prograf therapy followed by oral Prograf therapy
 Drug: Prograf
oral
Other Names:
  • FK506
  • tacrolimus
Drug: Prograf
intravenous
Other Names:
  • FK506
  • tacrolimus

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339468

Contacts
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01339468     History of Changes
Other Study ID Numbers: MR-08-04-KOR_Main
Study First Received: April 12, 2011
Last Updated: October 17, 2012
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013