AION-301 for Chronic Kidney Disease Stage 3

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)

Recruiting Phase 1 Phase 2 Interventional Study
Chronic Kidney Disease Stage 3
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
35 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
AION Healthspan, Inc. · Industry
Who this trial is looking for

This trial is looking for adults aged 35 to 75 with Stage 3 Chronic Kidney Disease. Participants will receive two infusions of either AION-301 or a placebo over a few days and will attend several clinic visits for checkups and tests.

Are You a Good Fit for This Trial?
Must be taking ACE inhibitorsARBSGLT2 inhibitors
Rules you out Recent heart attackRecent strokeAcute kidney injuryHistory of deep vein thrombosisHistory of lung disease

You may be able to join if

  • I am aged 35 to 75 years old.
  • I have been diagnosed with chronic kidney disease stage 3.
  • I can communicate well and understand the study information.
  • I am willing to stick to the treatment plan and visit schedule.
  • I have been on stable doses of certain kidney medications for at least 3 months.
  • I can give signed consent to participate.

You may not be able to join if

  • I have had a kidney transplant in the past or am scheduled for one soon.
  • I have had serious heart problems or poorly controlled high blood pressure recently.
  • I have a history of certain cancers within the last 5 years.
  • I have a history of significant kidney or autoimmune diseases.
  • I have experienced acute kidney injury recently.
  • I am currently pregnant, breastfeeding, or planning to become pregnant.
  • I cannot take certain medications like ACE inhibitors or SGLT2 inhibitors.
  • I have a significant medical history that may interfere with the study.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 A…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Patient is able to communicate well with the investigator, is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed i…
Contacts

Giacomo Lanzoni, PHD

+1786-285-9512

glanzoni@aionhealthspan.com

CONTACT

Desa Rae E Stanton-Pastore, MS

+1585-305-3850

dpastore@aionhealthspan.com

CONTACT