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Trial record 1 of 1 for:    NCT00619398
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A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients

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ClinicalTrials.gov Identifier: NCT00619398
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Liver Transplantation Drug: Prograf Drug: FK506MR capsule Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: 1 Drug: Prograf
Oral
Other Names:
  • tacrolimus
  • FK506

Experimental: 2 Drug: FK506MR capsule
Oral
Other Names:
  • Advagraf
  • tacrolimus modified release capsule
  • MR4
  • Prograf XL




Primary Outcome Measures :
  1. Event rate of patients with acute rejections [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Incidence of and time to acute rejections [ Time Frame: 12 Weeks ]
  2. Overall frequency of acute rejections [ Time Frame: 12 Weeks ]
  3. Rate of patients and graft survival following transplantation [ Time Frame: 12 Weeks ]
  4. Incidence of adverse events including laboratory assessments [ Time Frame: 12 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

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): NCT00619398


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

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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00619398     History of Changes
Other Study ID Numbers: MR4LTxCN02
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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