A Study to Investigate the Safety, Tolerability, and Preliminary Efficacy With AION-301 Administered by Intravenous Infusion Compared With Placebo Administered by Intravenous Infusion Investigational Intervention in Participants Aged 35 to 75 Years of Age With Chronic Kidney Disease (CKD)

Inclusion Criteria

• •Participants are eligible to be included in the study only if all of the following criteria apply:
• •Patient is able to communicate well with the investigator, is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, understands all requirements of the study, and understands and signs the written ICF before any study-specific procedure.
• •Willing and able to comply with the scheduled visits and treatment plan.
• •Either biological sex
• •Participant must be 35 to 75 years of age inclusive, at the time of signing the informed consent.
• •Diagnosis of CKD stage 3, G3 (a and b): persistent eGFR between 30 and 59 mL/min/1.73 m² (at least 2 measures within that range in the preceding 3 months, including the one at screening visit), and persistent increased Albuminuria (at least 2 measures within 3 months, including 1 before screening and 1 at screening (criterion for increased Albuminuria at screening: ≥2 out of 3 repeat daily early morning samples at screening) (UACR ≥ 200 mg/g and \< than 5000 mg/g)
• •Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and SGLT2 inhibitors (SGLT2i) unless such treatment is contraindicated or not tolerated\*. Treatment dose must be stable for at least 3 months prior to the date of the screening. If a patient is on treatment with GLP-1 receptor agonist, he/she should be on a stable dose for at least 3 months before screening.
• •\*Participants who are documented to be unable to take ACE inhibitors or ARBs or SGLT2i will be allowed to participate.
• •Female subjects must not be breastfeeding and must have no intention to become pregnant during the study, and she will be required to use at least two FDA approved birth control during the study. The FDA-approved and cleared methods for birth control are listed below:
• •* Permanent Sterilization
• •* Long-Acting Reversible Contraceptives (LARC)
• •* Contraceptive Injection
• •* Short-Acting Hormonal Methods
• •* Barrier Methods
• •* Emergency Contraception
• •Any male subject must agree to use contraceptives and not donate sperm during the study.
• •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.