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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT06863467
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects ≥18 to ≤ 80 years of age at screening
* Willing and able to provide written informed consent
* eGFR of ≥ 15 and ≤ 60 per
* Female subjects must be of non-childbearing potential or using a medically acceptable contraceptive regimen
* Male subjects must be surgically sterile or using a medically acceptable contraceptive regimen
* Willing and able to tolerate IV infusions and multiple blood draws
* Willing to comply with the study schedule, restrictions, and requirements
Exclusion Criteria:
* CKD Secondary to or associated with any of the following:
1. History of rapidly progressive glomerulonephritis (RPGN)
2. Glomerulonephritis requiring any use of immunosuppression in the last 6 months
* Body mass index ≤ 19.0 kg/m2 or ≥ 40.0 kg/m2
* Currently taking a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or non-steroidal mineralocorticoidantagonist (MRA) requiring dose adjustments within 12 weeks prior to Day 1 or if dose is anticipated to change
* Currently taking tumor necrosis factor (TNF) inhibitors, TNF blocker, interleukin-6 (IL-6) blockers or interleukin-1 (IL-1) blocking drugs
* Receiving steroids or any other immunosuppressive agent or anti-inflammatory drugs
* Currently taking an angiotensin-converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) requiring dose adjustments
* Any use of direct renin inhibitors;
* Live vaccinations within 3 months prior to the start of the trial or expected during the trial
* Received a mRNA vaccine within 4 weeks
* Uncontrolled diabetes (HbA1c \> 11.0%)
* Clinical laboratory results of ALT and/or AST that are \> 2.5X upper limit of normal (ULN)
* Clinical Laboratory results of Total bilirubin that is \> 1.5X the ULN
* Has a Urine Albumin-to-Creatinine Ratio (uACR) level \> 3000 mg/g
* Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial
* Uncontrolled hypertension
* New York Heart Association Class IV congestive heart failure
* Any organ transplant recipient, or a planned transplant during the study
* Currently has known Hepatitis B or uncontrolled human immunodeficiency virus (HIV) or uncontrolled Hepatitis C virus (HCV) that may interfere with the study
* Myocardial infarction, acute coronary syndrome, or stroke within 6 months
* History of myelodysplastic syndrome
* History of deep vein thrombosis (DVT) that required active treatment in the last 6 months. Superficial thrombosis is not excluded
* History of hemosiderosis or hemochromatosis
* History of rheumatoid arthritis or systemic lupus erythematosus (SLE)
* History of drug use that may interfere with the study or study result
* Red cell transfusion within 12 weeks
* History of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin or cervical carcinoma in situ
* Coronavirus disease 2019 (COVID-19) diagnosis within 1 month
* Evidence of active infection unless subject is appropriate for this study per the Investigator
* Life expectancy less than 6 months
* Intolerance to study medication
* Pregnancy or lactation
* Received treatment with any investigational product in any clinical study within 30 days prior to administration of study drug or five half-lives, whichever is longer
* In the opinion of the Investigator or identified Sub-I(s), any other disease processes or confounding variables that would inappropriately alter the outcome of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06863467
Study Brief:
Protocol Section:
NCT06863467