Eligibility Module

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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 @ 6:43 PM
Ignite Modification Date: 2025-12-24 @ 6:43 PM
NCT ID: NCT00001857
Eligibility Criteria: Must be a candidate for a renal transplant from a living related, living non-related, or cadaveric donor. Must be willing and able to give written informed consent. Aged between 18 and 65 years, inclusive. Subjects over the age of 65 may be considered on an individual basis based on medical suitability. Female subjects must be post-menopausal or surgically sterile, or using an acceptable method of contraception (oral contraceptives, Norplant, Depo-Provera, and barrier devices are acceptable; condoms used alone are not acceptable). WBC count must be greater than or equal to 3000/mm(2). No history of malignancy (except non-metastatic cutaneous squamous or basal cell carcinomas that have been completely excised without evidence of recurrence for at least 1 year). No active systemic bacterial, fungal or viral infections (including active zoster or herpetic lesions). No serological evidence of HIV, HCV, or HbsAg. No active peptic ulcer disease. No condition or circumstance that could potentially interfere with the evaluation of BG9588. No contraindication to monoclonal antibody therapies. No history of Major Thromboembolic event (e.g. stroke, pulmonary embolus). For the first 5 patients, no patient with a PRA greater than 20%. No previous participation in the study. No use of any investigational agent or device within 4 weeks prior to first dose of study drug. No Cold Ischemia Time of donor kidney greater than 36 hours. No uncontrolled non-heart-beating donor status. No positive T-cell Crossmatch.
Healthy Volunteers: False
Sex: ALL
Study: NCT00001857
Study Brief:
Protocol Section: NCT00001857