Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.

Korábbi kezelés

• 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
• Any organ transplant recipient, or a planned transplant during the study
• Intolerance to study medication
• 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

Más betegség

• CKD Secondary to or associated with any of the following:
  • History of rapidly progressive glomerulonephritis (RPGN)
  • Glomerulonephritis requiring any use of immunosuppression in the last 6 months
• Uncontrolled hypertension
• New York Heart Association Class IV congestive heart failure
• 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
• 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
• 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

Laborértékek

• 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
• 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

Életkor

• Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial

Egyéb

• Body mass index ≤ 19.0 kg/m2 or ≥ 40.0 kg/m2
• Red cell transfusion within 12 weeks
• Life expectancy less than 6 months
• Pregnancy or lactation

• 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