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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT01386359
Eligibility Criteria:
Inclusion Criteria:
* Adult kidney transplant recipient (age ≥18 years at time of transplant)
* Kidney-only transplant recipient
* Positive EBV serostatus
a) EBV serostatus negative or unknown included per the investigator discretion
* Received first dose of Nulojix (Belatacept) within ≤ 14 days of renal transplant
* Received first dose of Nulojix (Belatacept) as part of normal clinical care (i.e. not as part of a clinical trial)
Exclusion Criteria:
* Received Nulojix (belatacept) for non kidney transplants
* \<18 years of age at time of transplant
* Received first dose of Nulojix (belatacept) as an assigned study drug under a clinical trial protocol
* EBV-serostatus negative or unknown patients, except by investigator decision
* Patient who did not receive Belatacept for de novo treatment
* Recipient of concurrent or extant non-kidney organ transplant
* Received first dose of Nulojix (belatacept) \> 14 days after date of renal transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01386359
Study Brief:
Protocol Section:
NCT01386359