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 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT03663335
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained before any assessment.
* Male or female patient ≥ 18 years old.
* Up to date vaccination as per local immunization schedules.
* Recipients of a kidney transplant
* Recipients of a primary kidney transplant from a heart-beating deceased, living unrelated or non-HLA identical living related donors.
Exclusion Criteria:
* Multi-organ transplant recipients or prior kidney transplant.
* Recipients of an organ from a non-heart beating donor.
* Recipient of an organ from an HLA identical living related donor.
* ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant
* Recipients of kidneys from donors who are older than 65 years.
* Recipients of kidneys from donors with terminal serum creatinine \> 2 mg/dL.
* Patients at high immunological risk for rejection
* Patient who is anti-HIV positive, HBsAg-positive or anti-HCV positive (without proof of sustained viral response (SVR) after anti-HCV treatment).
* Recipient of a kidney from a donor who tests positive for HIV, HBsAg/HBc positive or HCV.
* A negative Epstein Barr virus (EBV) test.
* Evidence of advanced liver disease (Child-Pugh C), or any sign of liver decompensation.
* Patient with severe systemic infections, current or within the two weeks prior to randomization.
* History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized excised non-melanomatous skin lesions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03663335
Study Brief:
Protocol Section:
NCT03663335