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Chronic Kidney Disease Stage 3Phase 1/2UC-MSC-CKDNCT06721143

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 Phase 1/2 study testing AION-301 in people with Chronic Kidney Disease Stage 3, run by AION Healthspan, Inc. at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 75 years
Conditions the study is for
Chronic Kidney Disease Stage 3
What is being tested?
AION-301
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
2 sitesUnited States
Study dates
23 Jan 2025to May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 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)
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  • 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.
  • Participants who are documented to be unable to take ACE inhibitors or ARBs or SGLT2i will be allowed to participate.
  • 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.

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • 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).
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  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Giacomo Lanzoni, PHD contact

+1786-285-9512

glanzoni@aionhealthspan.com

Desa Rae E Stanton-Pastore, MS contact

+1585-305-3850

dpastore@aionhealthspan.com

United States2 sites, 2 recruiting

  • SouthCoast Research Center, Inc.

    Miami, Florida, 33136

    Oleg Leon-Pimentel, MD, 786-332-2721, sc6@southresearch.org

    Recruiting

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

    Miami, Florida, 33136

    Yelena R Drexler, MD, 305-243-6251, yrd6@med.miami.edu

    Recruiting

Other trials in United States

About this study

Official title: 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

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?
Read more

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.
Being tested
AION-301, Placebo
Keywords
CKD, AION-301, Stage 3 CKD, Chronic Kidney Disease
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AION-301Biological

    AION-301 Infusion

  • PlaceboDrug

    Placebo Infusion

Study groups in NCT06721143
Study groupRoleWhat they receive
Group IActive comparatorAION-301
Receives: Biological: AION-301
Group IIPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Treated Participants Experiencing Grade 3 or Above Adverse Events As Assessed by CTCAE V5.0

    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.

    Measured: From baseline through day 90

Secondary outcomes (4)

  1. To assess the potential evidence of efficacy in participants by

    The differences between groups in the proportion of patients with reduced proteinuria.

    Measured: From Baseline for up to 2 years

  2. To assess the potential evidence of efficacy in participants by

    Evaluations of effects and persistence of effects by measuring Urinary Albumin-to-Creatinine Ratio (UACR), Urinary Protein-to-Creatinine Ratio (UPCR), and estimated Glomerular Filtration Rate (eGFR).

    Measured: From Baseline for up to 2 years

  3. To assess the potential evidence of efficacy in participants by

    The impact of treatment on Quality of Life with the KDQOL-36 questionnaire.

    Measured: From Baseline for up to 2 years

  4. KidneyIntelX Risk Profile

    Changes in KidneyIntelX risk levels

    Measured: From baseline through 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start23 Jan 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06721143
Sponsor's protocol ID
AION-301-CKD-2024
Acronym
UC-MSC-CKD
Status last verified
Mar 2026
First submitted
7 Nov 2024
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AION-301 in people with Chronic Kidney Disease Stage 3, run by AION Healthspan, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Giacomo Lanzoni, PHD (+1786-285-9512, glanzoni@aionhealthspan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06721143.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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