A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619398
• Other study ID #: MR4LTxCN02
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2008
• Last updated: February 23, 2016
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

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
• FK506MR capsule
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate of patients with acute rejections		12 Weeks	No
Secondary	Incidence of and time to acute rejections		12 Weeks	No
Secondary	Overall frequency of acute rejections		12 Weeks	No
Secondary	Rate of patients and graft survival following transplantation		12 Weeks	No
Secondary	Incidence of adverse events including laboratory assessments		12 Weeks	Yes