Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients

Study Overview
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Brief Summary
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This study will compare the efficacy and safety of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil in Kidney Transplant Patients.

Conditions
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Kidney Transplant Patients

Intervention / Treatment
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* Drug: A) TEST
* Drug: B) CONTROL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged over 20 years Patient who is judged would have the benefits of the Extended Release Tacrolimus (Advagraf®)treatment by the investigator Patients has given written informed consent Patient is a recipient of primary or recipient of primary (a living kidney transplant, a cadaveric donor.) Patients has received an ABO compatible donor kidney. Complement-dependent Cytotoxic Crossmatch: CDC) result: negative Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization Exclusion Criteria: Patient has previously received an organ transplant other than a kidney. Patient has a known hypersensitivity to tacrolimus, Sirolimus (Rapamune®),Mycophenolate mofetil. Desensitization HLA-identical Heart Disease; Heart failure (symptom, EF <45%) Lung Disease; Significant chronic obstructive pulmonary disease, restrictive lung disease Patient has an uncontrolled concomitant infection (including Hepatitis B, Hepatitis C) or any other unstable malignant tumor history in the 5years prior to enrollment. (except,squamous cell carcinoma) Patient has received a kidney transplant from non-heart beating donor Cold ischemic time > 30hrs Elevated AST and/or ALT levels greater than 3 times the upper value of the normal range of the investigational site (ANC)<1,500/mm3, (WBC)<2,500/ mm3, (PLT)<100,000/ mm3 ATG: Anti-thymocyte globulin induction Medical condition that could interfere with the study objectives. Patient is currently taking or has been taking an investigational products in the 30 days prior to enrollment. Patient is currently taking or has been taking an prohibited medications in the 28 days prior to enrollment. Patient who is judged not to be adequate by the investigator owing to other reasons Patient is pregnant or lactating. Recipient or donor is known to be seropositive for human immunodeficiency virus.(HIV)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A) TEST<br> | Drug: A) TEST<br>* Extended Release Tacrolimus (Advagraf®) ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. Sirolimus (Rapamune®): After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.<br>* Other names: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®);Drug: B) CONTROL<br>* Extended Release Tacrolimus (Advagraf®) : Same as above. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid<br>* Other names: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil;|
| Experimental: B) CONTROL<br> | Drug: A) TEST<br>* Extended Release Tacrolimus (Advagraf®) ① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. ② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level. Sirolimus (Rapamune®): After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level.<br>* Other names: 1. Test group : Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®);Drug: B) CONTROL<br>* Extended Release Tacrolimus (Advagraf®) : Same as above. Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid<br>* Other names: 2. Control group: Extended Release Tacrolimus (Advagraf®) + Mycophenolate mofetil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate in effectiveness of up to 12 months after kidney transplant | Biopsy confirmed acute rejection Subjects and graft survival Glomerular filtration rate (GFR) 24-hour urine test results at 12 months after kidney transplant: Urine protein, CrCl. | 12 months after kidney transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RECORD study