Status:
COMPLETED
A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
Lead Sponsor:
Astellas Pharma Korea, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.
Eligibility Criteria
Inclusion
- Patients received a kidney transplant at least 12 months ago prior to enrollment.
- Patients have taken unchanged dosage of Prograf® and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment.
- Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
- Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial.
- Patients are considered clinically stable by observer's judgment.
- Patients must understand the purpose and risk of participating the trial and signed on the written consent.
Exclusion
- Patients have previously received an organ transplant other than a kidney.
- Patients have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
- Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
- Patients have a known hypersensitivity to Prograf® or tacrolimus.
- Patients whose medical condition are able to interfere with the study objectives.
- Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer.
- Patients have been participated in another clinical trial, or treated with drugs of clinical trial within 28 days prior to enrollment.
- Patients have been taken prohibited combination agents within 28 days prior to enrollment.
- Patients are pregnant or lactating.
- Patient are HIV-positive.
- Patients are not able to keep the scheduled visit.
- Patients whose GFR (MDRD) is in the level of \<30 mL/min.
- Patients who are at the condition of 'Creeping creatinine (defined by 20% increase within 6 months prior to enrollment)
- Patients whose SGPT/AST and/or SGOT/ALT levels have been elevated greater than 2 times the upper value of the normal range.
- Patients have FSGS or MPGN Type II as underlying diseases.
- Patients are with cirrhosis
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01839929
Start Date
September 1 2010
End Date
February 1 2013
Last Update
May 1 2013
Active Locations (4)
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1
Busan, South Korea
2
Daegu, South Korea
3
Daejeon, South Korea
4
Seoul, South Korea