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RECRUITING
NCT06721143
PHASE1/PHASE2

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)

Sponsor: AION Healthspan, Inc.

View on ClinicalTrials.gov

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.

Official title: A Double-blinded, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of AION-301 Administered by Intravenous Infusion for the Treatment of Participants With Stage 3 Chronic Kidney Disease

Key Details

Gender

All

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-01-23

Completion Date

2027-05

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

BIOLOGICAL

AION-301

AION-301 Infusion

DRUG

Placebo

Placebo Infusion

Locations (2)

SouthCoast Research Center, Inc.

Miami, Florida, United States

University of Miami, Leonard M. Miller School of Medicine

Miami, Florida, United States