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 Ye

• Status: RECRUITING
• Trial end date: 2027-12-01

Summary

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.

• Phase: PHASE1

Details

• Lead Sponsor: AION Healthspan, Inc.
• Collaborator: George Clinical