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Study identifier: NCT06721143 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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)

Condition: Chronic Kidney Disease Stage 3  ·  Sponsor: AION Healthspan, Inc.

PhasePhase 1/Phase 2
Planned participants36
Who can joinAll sexes, 35 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Giacomo Lanzoni, PHD  ·  +1786-285-9512  ·  glanzoni@aionhealthspan.com

Desa Rae E Stanton-Pastore, MS  ·  +1585-305-3850  ·  dpastore@aionhealthspan.com

Always discuss trial participation with your own doctor first.

Locations (2)

SouthCoast Research Center, Inc.Miami, Florida, United StatesRecruiting
University of Miami, Leonard M. Miller School of MedicineMiami, Florida, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06721143