Status:
WITHDRAWN
A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation
Lead Sponsor:
Genentech, Inc.
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 combinat...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00729768
Last Update
June 22 2017
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