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 @ 2:34 PM
Ignite Modification Date:
2025-12-24 @ 2:34 PM
NCT ID:
NCT06362759
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years at time of ICF signature.
* Serum hs-CRP level ≥2.0 mg/L and \<15 mg/L
* Diagnosis of chronic kidney disease, eGFR ≥15 and \<60 mL/min/1.73 m2 or eGFR ≥60 mL/min/1.73m2 and UPCR\>200 mg/g
* Received COVID-19 vaccine at least 30 days prior to the Screening visit, per participant verbal attestation.
* Agreement to comply with contraception and reproduction restrictions
Exclusion Criteria:
* Clinical evidence or suspicion of active infection
* Current or recent COVID-19 infection within 30 days
* Serious infection within 6 months or more than 1 such episode within 18 months
* Any history of a serious opportunistic infection within 18 months
* Known history of immunodeficiency
* History of gastrointestinal ulceration or perforation within 12 months
* History of active diverticulitis, active inflammatory bowel disease, or GI abscess within 12 months
* History of GI bleeding requiring hospitalization and/or transfusion within 6 months
* New York Heart Association Class III or IV congestive heart failure and/or hospitalization for heart failure exacerbation within 6 months
* Acute coronary syndrome, stroke, transient ischemic attack, or other thrombotic or thromboembolic event, or arterial revascularization procedure within 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06362759
Study Brief:
Protocol Section:
NCT06362759