Kidney Transplantation
Conditions
Keywords
Renal transplant, Raptiva
Brief summary
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.
Interventions
DRUGbasiliximab
2 intravenous doses
DRUGefalizumab
Subcutaneous repeating dose
DRUGmycophenolate mofetil
Oral repeating dose
DRUGcorticosteroids
Repeating doses
DRUGcyclosporine
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subject and renal allograft survival | 52 weeks |
Secondary
| Measure | 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 |
Outcome results
None listed