RecruitingPhase 1Phase 2NCT06721143

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)

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


Sponsor

AION Healthspan, Inc.

Enrollment

36 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 35 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AION-301, given through an IV infusion, in people with moderate chronic kidney disease (CKD stage 3). The goal is to see if the drug is safe and if it can slow the progression of kidney disease, particularly in people who still have significant protein leaking into their urine despite being on standard medications. **You may be eligible if...** - You are between 35 and 75 years old - You have CKD stage 3, meaning your kidney filtering rate (eGFR) is between 30 and 59, confirmed by at least 2 tests in the last 3 months - You have significant protein in your urine (UACR between 200 and 5000 mg/g) - You are already taking standard kidney-protective medications (such as an ACE inhibitor or ARB, plus an SGLT2 inhibitor) at the maximum tolerated dose, or these drugs are not suitable for you **You may NOT be eligible if...** - You are on dialysis or have had a kidney transplant - You have uncontrolled diabetes, poorly controlled blood pressure, or recent cardiovascular events - You have conditions that could interfere with how the drug is processed in your body - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAION-301

AION-301 Infusion

DRUGPlacebo

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

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NCT06721143


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