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)

Part of paid clinical trials in Miami, Florida.

Sponsor
AION Healthspan, Inc.
Study ID
NCT06721143
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Chronic Kidney Disease Stage 3

Eligibility Criteria

Sex
ALL
Age
35 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AION-301 — BIOLOGICAL
    AION-301 Infusion
  • Placebo — DRUG
    Placebo Infusion

Study Details

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.

Key Dates

Start date
Jan 23, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group I
    AION-301
  • Placebo Comparator: Group II
    Placebo

Primary Outcome Measure

Number of Treated Participants Experiencing Grade 3 or Above Adverse Events As Assessed by CTCAE V5.0 [ Time Frame: From baseline through day 90 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
SouthCoast Research Center, Inc.MiamiFlorida33136
Oleg Leon-Pimentel, MD
[email protected]
786-332-2721
University of Miami, Leonard M. Miller School of MedicineMiamiFlorida33136
Yelena R Drexler, MD
[email protected]
305-243-6251

Find similar trials in Miami, FL

By research site
SouthCoast Research Center, Inc.· Miami, FLUniversity of Miami, Leonard M. Miller School of Medicine· Miami, FL

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