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A Study of AION-301 for Chronic Kidney Disease Stage 3

This study is testing a new treatment called AION-301 for adults aged 35 to 75 with Stage 3 Chronic Kidney Disease (CKD). Researchers want to see if two intravenous (IV) infusions of AION-301 are safe and if they can reduce or delay CKD symptoms. You would receive either AION-301 or a placebo (an inactive substance) through an IV. The main goal is to track any medical problems (adverse events) that happen after treatment. The study also aims to understand how AION-301 works and if it helps people feel better. The study is currently unclear on its recruitment status and plans to enroll 36 participants.

Study design
This interventional study will compare AION-301 to a placebo. It plans to enroll 36 participants, but the phase is not specified.
What's involved
Participants will receive two infusions of AION-301 or placebo on two separate days (Day 0 and Day 4).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from baseline through day 90 to assess for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06721143

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
PHASE1Ages 35–75InterventionalTreatment
AION Healthspan, Inc.
~36 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:AION-301Placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Treated Participants Experiencing Grade 3 or Above Adverse Events As Assessed by CTCAE V5.0
Measured over From baseline through day 90

Conditions

Chronic Kidney Disease Stage 3

Explore related trials

Chronic Kidney Disease

NCT06721143

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • SouthCoast Research Center, Inc.

    Miami, Floridastudy coordinator listed

    Recruiting

  • University of Miami, Leonard M. Miller School of Medicine

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Giacomo Lanzoni, PHD
[email protected]
+1786-285-9512
Email the study team

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Eligibility criteria

Inclusion

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 in the informed consent form (ICF) and in this protocol, understands all requirements of the study, and understands and signs the written ICF before any study-specific procedure.
Willing and able to comply with the scheduled visits and treatment plan.
Either biological sex
Participant must be 35 to 75 years of age inclusive, at the time of signing the informed consent.
Diagnosis of CKD stage 3, G3 (a and b): persistent eGFR between 30 and 59 mL/min/1.73 m² (at least 2 measures within that range in the preceding 3 months, including the one at screening visit), and persistent increased Albuminuria (at least 2 measures within 3 months, including 1 before screening and 1 at screening (criterion for increased Albuminuria at screening: ≥2 out of 3 repeat daily early morning samples at screening) (UACR ≥ 200 mg/g and \< than 5000 mg/g)
Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), and SGLT2 inhibitors (SGLT2i) unless such treatment is contraindicated or not tolerated\*. Treatment dose must be stable for at least 3 months prior to the date of the screening. If a patient is on treatment with GLP-1 receptor agonist, he/she should be on a stable dose for at least 3 months before screening.
Female subjects must not be breastfeeding and must have no intention to become pregnant during the study, and she will be required to use at least two FDA approved birth control during the study. The FDA-approved and cleared methods for birth control are listed below:
Permanent Sterilization
Long-Acting Reversible Contraceptives (LARC)
Contraceptive Injection
Short-Acting Hormonal Methods
Barrier Methods
Emergency Contraception
Any male subject must agree to use contraceptives and not donate sperm during the study.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion

Prior transplant of any organ (including BM and stem cell transplant) or kidney transplant scheduled in the next 6 months.
Proteinuria\>5000 and or serum Albumin\< 2.5 g/dl.
Acute coronary syndrome, stroke or TIA or hospitalization for heart failure in previous 12 weeks or poorly controlled hypertension (≥160/100 mmHg at screening visit) or SBP\<90 at screening visit.
History of malignancy (except successfully treated squamous and basal cells skin carcinoma) within 5 years of screening.
History of atrial fibrillation (AF, AFib).
CKD due to genetic disorder.
History of systemic Autoimmune diseases like T1D, SLE or CKD caused by any autoimmune kidney disease.
Acute Kidney Injury (AKI) defined as increase in serum creatinine ≥1.5 times baseline in the previous 3 months or by presence of acute tubular injury in kidney biopsy in the previous 3 months.
Dialysis for acute renal failure within 12 weeks of screening visit.
Rapidly progressive kidney disease (eGFR reduction ≥ 30% over the last three months)
HbA1c ≥ 8.5%.
BMI ≥35 kg/m2.
Disorder of coagulation (including any history of thrombotic or thromboembolic disease) and/or long-term anti-coagulant therapy
History of Deep Vein Thrombosis (DVT)
History of Acute Pulmonary Embolism
History of solitary kidney.
On medications such as immunosuppressant, monoclonal antibodies, anabolic steroids, at the time of screening or in the previous 6 months and/or illicit drugs.
History of alcohol abuse or cigarette smoking in the previous 6 months.
Pregnancy or breast feeding at the time of screening, or with intention to become pregnant or breast-feeding during the course of the study, including the follow-up period.
History of liver disease, ALT and AST ≥3 x ULN, positive serology for Hepatitis B or Hepatitis C, HIV.
A significant medical history or abnormality at the physical exam that, in the judgment of the principal investigator, may interfere with the study.
Presence of any active infection, including COVID 19
Any clinically significant pulmonary disease
History of hypersensitivity to study drug and/or any of its excipients.
Close affiliation with the investigational site; for example, a close relative of the investigator, dependent person (for example employee or student of the investigational site).
Panel Reactive Antibodies (PRA) \>0% (positive)

What this trial measures

  • Number of Treated Participants Experiencing Grade 3 or Above Adverse Events As Assessed by CTCAE V5.0From baseline through day 90

    The primary analysis will be to test safety and tolerability AION-301 DP treatment in patients with CKD as assessed by the proportion of patients experiencing adverse events grade 3 or above (based on CTCAE version 5) by day 90 following treatment in comparison with Placebo group. This will be conducted by the unblinded trial biostatistician using standard two sample tests of proportions such as chi-squared tests or Fisher's exact tests.