Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation

Study Overview
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Brief Summary
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Comparison of outcomes/safety/and tolerability of SRL/FK/Pred vs. FK/MMF/Pred vs. SRL/Neoral®/Pred in cadaveric and non-HLA identical LRD kidney transplants.

Official Title
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Tacrolimus and Mycophenolate Versus Tacrolimus and Sirolimus vs. Neoral and Sirolimus Used in Combination in Cadaver and Non-HLA Identical Living Related Kidney Transplants

Conditions
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Adult Primary Kidney Transplantation

Intervention / Treatment
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* Drug: Tacrolimus/Sirolimus
* Drug: Tacrolimus/MMF
* Drug: Neoral/Sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >14 years Weight > 40 kg Primary renal allograft: cadaveric or mismatched living donor Negative standard cross match for T-cells Women of childbearing potential will be required to have a negative qualitative serum pregnancy test and agree to use an adequate method of contraception throughout the study period and for 3 months after discontinuation of study medication (3yrs, 3 mos.) Signed and dated informed consent (Parent or legal guardian must provide written consent for patients <18 years of age) Exclusion Criteria: Evidence of systemic infection History of malignancy within 10 years (with the exception of localized skin cancer) Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole Known hypersensitivity to sirolimus and its derivatives 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 > 200mg/dl

Ages Eligible for Study
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Minimum Age: 16 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 |
| --- | --- |
| Experimental: A<br>Tacrolimus/Sirolimus | Drug: Tacrolimus/Sirolimus<br> <br> |
| Experimental: B<br>Tacrolimus/MMF | Drug: Tacrolimus/MMF<br> <br> |
| Experimental: C<br>Neoral/Sirolimus | Drug: Neoral/Sirolimus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of acute rejection episodes |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Graft loss 2. Renal function as determined by serum creatinine and calculated creatinine clearance (using the Cockcroft-Gault method) six and 12 months |  | 1, 3, and 5 years |