Study Evaluating Sirolimus in Kidney Transplant Recipients.

Study Overview
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Brief Summary
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Renal function at 12 months assessed by calculated creatinine clearance.

Official Title
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A Randomized, Open Label Study to Evaluate the Effects of a Regimen With Sirolimus,Low Doses Cyclosporine and Steroids vs a Regimen With Sirolimus and Steroids, After an Induction Period With Basiliximab, Sirolimus,Cyclosporine and Steroids in de Novo Renal Transplant Patients.

Conditions
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Kidney Failure, Graft vs Host Disease

Intervention / Treatment
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* Drug: Cyclosporine
* Drug: Steroids
* Drug: Rapamune (Sirolimus)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is older than 18 years. End-stage renal disease, with subjects scheduled for kidney transplant. Women of childbearing potential must not be pregnant and agree to medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment. Other inclusion applies. Exclusion Criteria: Evidence of active systemic or localized major infection. Use of any investigational drug or treatment up to 4 weeks prior to study entry. Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, basiliximab. Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant). Immunosuppression therapies other than those allowed in the protocol. Treatment with voriconazole, terfenadine, cisapride, astemizole, pimozide, or ketoconazole (all known to interact with SRL) that is not discontinued prior to study entry. Other exclusion applies.

Ages Eligible for Study
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Minimum Age: 18 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<br> | Drug: Cyclosporine<br>* Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped <br>Drug: Steroids<br>* Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped <br>Drug: Rapamune (Sirolimus)<br>* Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped <br>|
| Experimental: B<br> | Drug: Cyclosporine<br>* Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped <br>Drug: Steroids<br>* Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped <br>Drug: Rapamune (Sirolimus)<br>* Arm 1= Rapamune+ low dose Cyclosporine+steroids Arm 2= 1° day rapamune 15 mg/die + steroids 2°-7° day Rapamune 5mg/die + steroids In both arms, Cylcoporine is stopped <br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and efficacy of an immunosuppressive regimen using synergic action of SRL and CsA, but which will limit (ab initio), the nephrotic effect of such combination. To compare Rapamune/low dose Cyclosporine vs. Rapamune/Steroids. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney, Transplant