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A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients
This study has been completed.
First Received: January 23, 2008   Last Updated: March 10, 2009   History of Changes
Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00619398
  Purpose

This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.


Condition Intervention Phase
Liver Transplantation
Drug: Prograf
Drug: FK506MR capsule
Phase III

MedlinePlus related topics: Liver Transplantation
Drug Information available for: Tacrolimus anhydrous Tacrolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients and a Pharmacokinetics Study

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of patients with acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of and time to acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Overall frequency of acute rejections [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Rate of patients and graft survival following transplantation [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events including laboratory assessments [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 172
Study Start Date: January 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator Drug: Prograf
Oral
2: Experimental Drug: FK506MR capsule
Oral

Detailed Description:

A multicentre, randomized, open label, two parallel group study The patients will be randomized to MR4 group or Prograf® group. The treatment period is 3 months( 12 weeks).Patients randomized to MR4 group who complete 3 months treatment period will continue to use MR4 until MR4 commercial available or authority notification.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent with the date of the patient must be obtained
  2. Patient is the recipient of a liver transplant from 6 to 24 months prior to enrollment
  3. Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
  4. At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is <= 2 times the upper value of normal range)
  5. Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator

Exclusion Criteria:

  1. Patient has received an organ transplant other than a kidney
  2. Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
  3. Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
  4. Patient with liver recurrent cancer, or metastasis, or other cancer
  5. Patient has any unstable medical condition that could interfere with the study objectives
  6. Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment
  7. Patient is allergic macrolide antibiotics or tacrolimus
  8. Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator
  9. Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00619398

Locations
China
Beijing, China
Shanghai, China
Tianjing, China
China, Guangdong
Guangzhou, Guangdong, China
China, Liaoning
Shenyang, Liaoning, China
China, Zheijiang
Hangzhou, Zheijiang, China
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc. ( Director )
Study ID Numbers: MR4LTxCN02
Study First Received: January 23, 2008
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00619398     History of Changes
Health Authority: China: State Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
FK506
tacrolimus
prograf
Liver transplantation

Study placed in the following topic categories:
Immunologic Factors
Tacrolimus
Immunosuppressive Agents

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

ClinicalTrials.gov processed this record on May 07, 2009