Comparison of Tacrolimus and Myfortic Versus Tacrolimus and Sirolimus

Study Overview
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Brief Summary
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The investigators center has also analyzed data over the last 7 years from deceased donor (DD) and living donor (LD) kidney transplant recipients who were randomized into 3 immunosuppressive arms between 2000 and 2001. Thus the goal of the investigators study is to reduce the toxic effects of traditional immunosuppressive regimens involving high-dose calcineurin inhibitor agents by comparing low-dose TAC-MYF with low-dose TAC and de novo SRL regimens. In order to minimize exposure to TAC, the investigators center has previously shown favorable outcomes using combination Thymoglobulin and Zenapax (Daclizumab) for anti-lymphocyte induction in the investigator population of patients.

Detailed Description
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A total of 150 randomized patients divided into 2 arms: 75 patients will be randomized to receive TAC-SRL, and 75 patients to receive TAC-MYF.

Official Title
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Head to Head Comparison of Tacrolimus and Myfortic vs Tacrolimus and Sirolimus Used in Combination in Non-HLA Identical Living Donor Kidney Transplants

Conditions
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Living Donor Kidney Transplants Patients

Intervention / Treatment
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* Drug: Tacrolimus, Myfortic and Sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-HLA identical living donor kidney transplant patients Exclusion Criteria: Patient has previously received or is receiving an organ transplant other than a kidney. Patient is receiving an ABO incompatible donor kidney. Recipient or donor is known seropositive for human immunodeficiency (HIV) or Hepatitis C virus, or Hepatitis B virus antigenemia. 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, or carcinoma in-situ of the cervix that has been treated successfully. Patients with 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 at our center. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with study objectives. Patient is currently participating in another clinical trial of an investigational drug in the 30 days prior to transplant. Patient will be receiving any immunosuppressive agent other than those prescribed in the study. Patient is unable to take medications orally or via nasogastric tube by the morning of the second day following completion of the transplant procedure (i.e., skin closure). Patient is receiving or may require Warfarin, Fluvastatin, or herbal supplements during the study. Concurrent use of Astemizole, Pimozide, Cisapride, Terfenadine, or Ketoconazole. Patient has a known hypersensitivity to Tacrolimus, Thymoglobulin®, IL-2 receptor inhibitor monoclonal antibodies, Rapamune, Myfortic®, or corticosteroids. Patient is pregnant or lactating. Patients with a screening/baseline (or within 96 hours of transplant) total white blood cell count <4000/mm3; platelet count <100,000/mm3; fasting triglycerides >400 mg/dl (>4.6 mmol/L); fasting total cholesterol >300 mg/dl (>7.8 mmol/L); fasting HDL-cholesterol <30 mg/dl; fasting LDL-cholesterol >200 mg/dl. Patient is unlikely to comply with the visits scheduled in the protocol. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator. If Tacrolimus cannot be instituted for longer than 5 days postoperatively.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Tacrolimus and Myfortic<br>Immunosuppressive | Drug: Tacrolimus, Myfortic and Sirolimus<br>* Immunosuppressive drugs<br>|
| Active Comparator: Tacrolimus and Sirolimus<br>Immunosuppressive | Drug: Tacrolimus, Myfortic and Sirolimus<br>* Immunosuppressive drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the time to initiation of the comparison study |  | 3 years |