A Study to Assess the Safety and Efficacy of Prograf and MR4 in Liver Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00719745
First received: July 18, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

To evaluate and to compare efficacy and safety of MR4 versus Prograf in patients undergoing primary liver transplantation.


Condition Intervention Phase
Liver Transplantation
Drug: Prograf
Drug: MR4
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Liver Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of patients with biopsy-proven acute rejections [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of and time to acute rejections and corticosteroid resistant acute rejections [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Severity of biopsy-proven acute rejections. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patient and graft survival [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Throughout trial ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: February 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Prograf
oral
Other Names:
  • Tacrolimus
  • FK506
Experimental: 2 Drug: MR4
oral
Other Names:
  • Modified Release Tacrolimus
  • FK506MR
  • FK506E

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients of child bearing potential must have a negative in pregnancy test prior to enrollment and must agree to practice effective birth control during the study
  • Patients who need liver transplantation due to the end-stage liver failure

Exclusion Criteria:

  • Patients receiving multi-organ transplant or having previously received an organ transplant ( including re-transplantation)
  • Patients receiving auxiliary graft or in whom a bio-artificial
  • Patients allergic to macrolide antibiotics or tacrolimus
  • Patients requiring immunosuppressive treatment or systemic chemotherapy prior to transplantation. Patients requiring low level immunosuppressive treatment ( MMF, steroids, azathioprine ) before transplantation to control their original liver disease can be included in the study, provided that this treatment is discontinued at the time of transplantation. Local chemotherapy is allowed
  • Patients with malignancies of a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully Patients can be included under Milan Criteria Patients with malignancy which was identified after completion of surgery e.g. by histopathology will be allowed to remain in the study
  • Patients with systemic infection requiring treatment, except viral hepatitis
  • Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
  • Patients with serum creatinine > 1.5mg/Dl
  • Patients with any form of substance abuse, psychiatric disorder of condition which, in the opinion of the investigator, may complicate communication with the investigator
  • Patients participating or participated in another clinical trial or those taking or having taken an investigational / non-registered drug in the past 28 days
  • Patients who are pregnant or breast-feeding mother
  • Patients or donors known to be HIV positive
  • Patients unlikely to comply with the visits scheduled in the protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719745

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

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00719745     History of Changes
Other Study ID Numbers: MR-05-02-KOR
Study First Received: July 18, 2008
Last Updated: July 18, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Organ transplantation
Tacrolimus
Prograf
MR4

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

ClinicalTrials.gov processed this record on October 19, 2014