A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Study Overview
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Brief Summary
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This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.

Official Title
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A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen in De Novo Renal Transplantation

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: basiliximab
* Drug: efalizumab
* Drug: mycophenolate mofetil
* Drug: corticosteroids
* Drug: cyclosporine


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have signed the informed consent form and the HIPAA patient information form (United States only) Are ≥ 18 years of age Are a transplant recipient of at least one HLA-mismatch kidney For subjects of reproductive potential (men and women), are willing to use effective contraception, unless abstinence is the chosen method Key Exclusion Criteria: Have a history of previous renal transplant Have had a PRA > 25% at any time Have a history of or evidence of cancer except for basal cell carcinoma that has been excised and cervical carcinoma in situ Have a positive T-cell lymphocytotoxic crossmatch with the use of donor lymphocytes and recipient serum Have had previous treatment with efalizumab Have used any investigational drug within 28 days or 5 half-lives of screening, whichever is longer Have a known contraindication to efalizumab Have a history of severe allergic or anaphylactic reactions to monoclonal antibodies Have had a known allergic reaction or intolerance to any of the following medications: CsA; MMF; Corticosteroids; Basiliximab Are allergic to iodinated contrast media that would preclude GFR measurement with iothalamate

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 |
| --- | --- |
| Experimental: 1<br> | Drug: basiliximab<br>* 2 intravenous doses<br>Drug: efalizumab<br>* Subcutaneous repeating dose<br>Drug: mycophenolate mofetil<br>* Oral repeating dose<br>Drug: corticosteroids<br>* Repeating doses<br>|
| Active Comparator: 2<br> | Drug: basiliximab<br>* 2 intravenous doses<br>Drug: mycophenolate mofetil<br>* Oral repeating dose<br>Drug: corticosteroids<br>* Repeating doses<br>Drug: cyclosporine<br>* Oral repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject and renal allograft survival |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glomerular filtration rate |  | 12 and 52 weeks | 
| Change in glomerular filtration rate |  | 12 weeks to 52 weeks | 
| Transplant renal biopsies |  | 52 weeks | 
| Change in metabolic/cardiovascular risk factors |  | 24 weeks and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant, Raptiva