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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719745
• Other study ID #: MR-05-02-KOR
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2008
• Last updated: July 18, 2008
• Start date: February 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Prograf
oral
• MR4
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate of patients with biopsy-proven acute rejections		24 weeks	No
Secondary	Incidence of and time to acute rejections and corticosteroid resistant acute rejections		12 and 24 weeks	No
Secondary	Severity of biopsy-proven acute rejections.		24 weeks	No
Secondary	Patient and graft survival		12 and 24 weeks	No
Secondary	Incidence of adverse events		Throughout trial	Yes