The goal of this clinical trial is to learn about the safety (good or bad) of giving two AION-301 intravenous (IV) infusions, in adults with Stage 3 Chronic Kidney Disease (CKD). It will also help to learn if AION-301 reduces the symptoms of CKD and/or progression. The main questions it aims to answer are:
* Do participants have medical problems (adverse events) after receiving two infusions of AION-301? * Do participants feel better (have reduced and/or delayed CKD symptoms)? * To learn about how AION-301 works in participants with CKD?
Researchers will compare AION-301 to a placebo (a look-alike substance that contains no drug) to see if AION-301 works to treat Stage 3 CKD.
Participants will:
* Receive two infusions of AION-301 or placebo on two separate days (Day 0 and Day 4). * Receive oral vitamins at the clinic and to take at home for 90 days. * Visit the clinic for a minimum of 9 times, over 6 months for checkups and tests, but could be up to 12 times, over 24 months for checkups and tests.
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.
Prior transplant of any organ (including BM and stem cell transplant) or kidney transplant scheduled in the next 6 months.
Proteinuria>5000 and or serum Albumin< 2.5 g/dl.
Acute coronary syndrome, stroke or TIA or hospitalization for heart failure in previous 12 weeks or poorly controlled hypertension (≥160/100 mmHg at screening visit) or SBP<90 at screening visit.
History of malignancy (except successfully treated squamous and basal cells skin carcinoma) within 5 years of screening.
AION Healthspan, Inc.
Lead sponsor
George Clinical
Collaborator