New drug gemini tested for kidney disease safety

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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