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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT02176434
Eligibility Criteria:
Inclusion Criteria:
* Patients, who are eligible for kidney transplantation
* Males or females 18 - 70 years of age.
* Subjects must have an HLA-matched sibling donor 25-70 years of age
* Men and women of reproductive potential must agree to use a reliable method of birth control
* Ability to understand and provide informed consent.
Exclusion Criteria:
* Evidence of uncontrolled active infection (including replicating HIV, Hepatitic B and Hepatitis C) as defined by:
1. clinical syndrome consistent with viral or bacterial infection, or
2. fever with a clinical site of infection identified, or
3. microbiologically documented infection
* Contraindication to therapy with any one of the proposed agents (e.g. allergy to ATG).
* Serologic positivity to HIV.
* Women of childbearing age in whom adequate contraception cannot be maintained, pregnant women or nursing mothers.
* Malignancy within the past two years, for which waiting time for transplantation is required by PENN registry consult, thereby excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
* Liver transaminases \> 3 x normal value.
* Cardiac ejection fraction \< 50% by radionuclide ventriculography or echocardiography.
* Forced Expiratory Volume (FEV1) \< 50% predicted or corrected Diffusing Capacity for Carbon Monoxide (DLCO) \< 50 % predicted.
* Blood group incompatibility in the host-vs-graft direction.
* High risk of primary kidney disease recurrence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02176434
Study Brief:
Protocol Section:
NCT02176434