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 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT00078559
Eligibility Criteria:
Inclusion Criteria
* Kidney transplant with primary cadaveric or non-Human Leukocyte Antigen (HLA)-identical living donor kidney (0-3 HLA-antigen mismatch)
* Receiving only a kidney and no other organs
* Able to take medications by mouth
* Willing to use acceptable methods of contraception
Exclusion Criteria
* Received HLA-identical living-donor kidney transplant
* HLA-antigen mismatch greater than 3
* Panel reactive antibody (PRA) value greater than 10% at any time prior to enrollment
* Received a non-heart-beating donor allograft
* Received a kidney from a donor who is greater than 60 years of age
* End-stage Renal Disease (ESRD) due to Focal Segmental Glomulerosclerosis (FSGS)
* Previous kidney transplant
* Received multiorgan transplant
* Concomitant systemic corticosteroid therapy for other medical diseases
* Known hypersensitivity to alemtuzumab, tacrolimus, methylprednisolone, or sirolimus
* Human Immunodeficiency Virus (HIV) infected
* Hepatitis C virus infected
* Positive for hepatitis B surface antigen
* Received dual or en-bloc pediatric kidneys
* Anti-human Globulin (AHG) or T cell crossmatch positive
* Investigational drug within 6 weeks of study entry
* Known clinically significant cardiovascular or cerebrovascular disease
* Previous or current history of cancer or lymphoma. Patients with adequately treated basal or squamous cell skin carcinoma are not excluded.
* Clinically significant coagulopathy or a requirement for chronic anti-coagulation therapy precluding biopsy
* Cytomegalovirus (CMV)-negative recipient, if received kidney is from a CMV-positive donor
* History of a psychological illness or condition that, in the opinion of the investigator, may interfere with the study
* Graves disease. Patients who have been previously adequately treated with radioiodine ablative therapy are not excluded.
* Active systemic infections
* Platelets less than 100,000 cells/mm\^3 at study entry
* Pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00078559
Study Brief:
Protocol Section:
NCT00078559