Actively Recruiting
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)
Led by AION Healthspan, Inc. · Updated on 2026-04-01
36
Participants Needed
2
Research Sites
118 weeks
Total Duration
On this page
Sponsors
A
AION Healthspan, Inc.
Lead Sponsor
G
George Clinical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to communicate well and provide signed informed consent
- Willing and able to comply with scheduled visits and treatment plan
- Biological sex of any kind
- Aged 35 to 75 years inclusive at time of consent
- Diagnosed with Stage 3 CKD, with persistent eGFR between 30 and 59 mL/min/1.73 m² confirmed by at least two measures in the past 3 months
- Persistent increased Albuminuria confirmed by at least two measures in 3 months, including one before and one at screening (UACR ≥ 200 mg/g and < 5000 mg/g)
- On maximum labeled or tolerated dose of RAAS blockers including ACE inhibitors or ARBs, and SGLT2 inhibitors unless contraindicated or not tolerated, with stable dose for at least 3 months prior; stable dose of GLP-1 receptor agonist for 3 months if applicable
- Female subjects must not be breastfeeding and must agree to use at least two FDA-approved birth control methods during the study
- Male subjects must agree to use contraceptives and not donate sperm during the study
- Contraceptive use must follow local regulations
You will not qualify if you...
- Prior organ transplant or scheduled kidney transplant within 6 months
- Proteinuria > 5000 mg/g or serum Albumin < 2.5 g/dl
- Recent acute coronary syndrome, stroke, TIA, or hospitalization for heart failure in past 12 weeks
- Poorly controlled hypertension (≥160/100 mmHg) or low systolic blood pressure (<90 mmHg) at screening
- History of malignancy within 5 years except treated skin carcinoma
- History of atrial fibrillation
- CKD due to genetic disorders
- History of systemic autoimmune diseases like Type 1 Diabetes, SLE, or autoimmune kidney disease
- Acute Kidney Injury within past 3 months
- Dialysis for acute renal failure within 12 weeks
- Rapidly progressive kidney disease with eGFR reduction ≥30% over last 3 months
- HbA1c ≥ 8.5%
- Body mass index ≥ 35 kg/m²
- Coagulation disorders or long-term anticoagulant therapy
- History of deep vein thrombosis or acute pulmonary embolism
- History of solitary kidney
- Use of immunosuppressants, monoclonal antibodies, anabolic steroids, or illicit drugs in past 6 months
- History of alcohol abuse or cigarette smoking in past 6 months
- Pregnancy or breastfeeding at screening or planning during study
- Liver disease with elevated enzymes or positive viral hepatitis/HIV serology
- Significant medical history or abnormalities interfering with study
- Active infection including COVID-19
- Clinically significant pulmonary disease
- Hypersensitivity to study drug or excipients
- Close affiliation with investigational site staff
- Panel reactive antibodies (PRA) > 0%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
SouthCoast Research Center, Inc.
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Miami, Leonard M. Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
G
Giacomo Lanzoni, PHD
CONTACT
D
Desa Rae E Stanton-Pastore, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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