Status:
COMPLETED
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
19-65 years
Phase:
PHASE3
Brief Summary
To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients
Eligibility Criteria
Inclusion
- Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment
Exclusion
- Patient has previously received an organ transplant other than a kidney
- Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
- Patients has received an ABO incompatible donor kidney
- Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
- Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
- Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
- Patient has a known hypersensitivity to tacrolimus
- Patient is pregnant or lactating
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00720265
Start Date
February 1 2006
End Date
March 1 2008
Last Update
July 22 2008
Active Locations (2)
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1
Daegu, South Korea
2
Seoul, South Korea