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 @ 3:07 PM
Ignite Modification Date:
2025-12-24 @ 3:07 PM
NCT ID:
NCT04773392
Eligibility Criteria:
Inclusion Criteria:
* De- Novo Kidney transplant patients between 18 and 85 years old
* Cold ischemia time (CIT) \< 24 hours for 3-6 HLA mismatches between donor and recipient and CIT \>24 hours for HLA mismatch of less than 3 between donor and recipient
* Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%
Exclusion Criteria:
* Repeat kidney transplant recipients
* cPRA \>20%
* rATG (rabbit anti-thymocyte globulin) induction \>6mg/kg at time of induction
* Crossmatches deemed positive by accepting physician
* Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing.
* Receipt of desensitization protocols
* History of skin cancer
* Recipient of multi-organ or dual kidney transplants
* For any condition, in which the investigator's opinion makes the subject unsuitable for study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04773392
Study Brief:
Protocol Section:
NCT04773392