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 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT01035593
Eligibility Criteria:
Inclusion Criteria:
* Recipients of renal transplantation within 30 days prior to enrollment.
* AMR documented by light microscopic changes and immunohistochemical C4d staining on renal biopsy within 30 days post-transplant.
* Positive DSA as detected by magnetic microbeads using a Luminex® system.
* Age ≥ 18 years.
* Women of child-bearing potential (CBP) must have negative pregnancy test at screening.
* Women of CBP and men with sexual partners of CBP must agree to use a medically acceptable method of contraception throughout the study and for 3 months following discontinuation of assigned treatment.
* Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
Exclusion Criteria:
* Recipients of multi-organ transplants.
* Recipients with previous early AMR.
* Recipients with a known hypersensitivity to C1INH, rabbit anti-thymocyte globulin, or any rabbit protein.
* History of malignancy within 3 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
* Subjects who are positive for hepatitis C, hepatitis B surface antigen, or HIV at the time of transplant.
* Subjects who are actively taking an investigational drug.
* Subjects with a history of a psychological illness or condition that could interfere with the subject's ability to understand the requirements of the study.
* Female subjects who are pregnant or nursing.
* Subjects with hemodynamic instability, as defined by a mean arterial pressure (MAP) \<60 mmHg or \>110 mmHg; or requirement of vasopressors to maintain a MAP of 60 mmHg; or requirement of IV vasodilators for hypertensive emergency; or acute pulmonary edema.
* Subjects with known active infection at the time of enrollment.
* Biopsy-confirmed concurrent cellular rejection requiring polyclonal antibody therapy (i.e., all Grades other than Banff 1a and 1b will be excluded).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01035593
Study Brief:
Protocol Section:
NCT01035593