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Compares treatment options for Chronic Kidney Disease Stage 3
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)
ClinicalTrials.gov ID: NCT06721143
What this study is testing
What is AION-301?
AION-301 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic kidney disease stage 3.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- History of malignancy (except successfully treated squamous and basal cells skin carcinoma) within 5 years of screening.
- History of atrial fibrillation (AF, AFib).
See the full eligibility 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 in the informed consent form (ICF) and in...
- 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...
- 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)...
- Female people 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...
- 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.
- 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).
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.