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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)

NCT06721143 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease Stage 3

Interventions

BIOLOGICAL

AION-301

AION-301 Infusion

DRUG

Placebo

Placebo Infusion

Sponsors & Collaborators

  • George Clinical

    collaborator UNKNOWN

  • AION Healthspan, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-23
Primary Completion
2027-01-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721143 on ClinicalTrials.gov