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:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT01025193
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients aged 18 -75 years.
* Patients denied a kidney transplant because of a prior positive crossmatch
* Patients awaiting a first or second kidney transplant from a living or deceased donor
* Patients who have given written informed consent to participate in all aspects of the study.
* Patients with no potential living donors should have accumulated at least 12 months waiting time in our organ procurement organization
* And one of the following criteria:
* Pre-sensitized patients defined by Luminex antibody assays and whose panel reactive antibody (PRA) is 20% or greater
* Patients with a PRA of less than 20% but who have HLA antibody specificities to HLA-Cw, DP or allele-specific antigens
Exclusion Criteria:
* Patients with known hypersensitivity to belimumab or who have received biologics, within the last 90 days
* Patients receiving corticosteroids, intravenous immunoglobulin, cyclophosphamide, mycophenolate mofetil, or azathioprine from 90 days prior to study entry until day of transplant.
* Patients with a history of anaphylaxis to parenteral administration of contrast agents, foreign proteins, or monoclonal antibodies.
* Patients with multi-organ transplant
* Patients who have received any investigational immunosuppressive drug within 1 month of inclusion into this study or if use of such a product is anticipated.
* Patients who have received any live vaccine within 30 days of study entry.
* Female patients who are pregnant, lactating.
* Female patients of child bearing potential and not willing to practice an approved method of birth control for 1 month prior to the start of the study agent and 8 weeks after the last dose of study agent.
* Male patients who are not agreeable to using effective contraception throughout the study and for 3 months after the last dose of study agent.
* Patients with a known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin.
* Patients who are positive for Hepatitis B infection, Hepatitis C infection or Human Immunodeficiency Virus (HIV)-positive patients.
* Patients with evidence of severe liver disease, including abnormal liver profile tests \> 3 times upper limit of normal at screening.
* Patients with current severe infection.
* Patients with any surgical or medical condition, which in the opinion of the investigator precludes enrollment in this trial
* Patients who live far from the transplant center and are unable to comply with all study visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01025193
Study Brief:
Protocol Section:
NCT01025193