Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
NCT ID:
NCT00729768
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00729768
Study Brief:
Protocol Section:
NCT00729768