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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04154267
Eligibility Criteria:
Inclusion Criteria:
Adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. The high immune risk is defined by:
* Positive pre-transplant T-lymphocyte cross-test by flow cytometry (channel deviation greater than 62);
* Flow cytometry pre-transplantation positive B lymphocyte cross-test (channel deviation greater than 112);
* Calculated panel reactivity greater than 50% in class I and / or class II;
* Presence in the pre-transplantation serum of donor class I and / or II anti-Human Leukocyte Antigen antibodies with intensity and fluorescence greater than 1000;
* Occurrence of cellular or antibody-mediated rejection within 30 days prior to the date of the protocol biopsy.
Exclusion Criteria:
* Patients with contraindication to renal graft biopsy;
* Patients whose biopsy fragments are not representative;
* Patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04154267
Study Brief:
Protocol Section:
NCT04154267