AION-301 for Chronic Kidney Disease (UC-MSC-CKD Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by AION Healthspan, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CKD stage 3, G3 (a and b) with persistent eGFR between 30 and 59 mL/min/1.73 m² and persistent increased Albuminuria

Participant must be 35 to 75 years of age inclusive at the time of signing the informed consent

Must not have

Acute coronary syndrome, stroke, TIA, hospitalization for heart failure in previous 12 weeks, poorly controlled hypertension, or SBP < 90 at screening visit

History of malignancy within 5 years of screening, except successfully treated squamous and basal cells skin carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline for up to 2 years

Summary

This trial aims to test the safety and effectiveness of giving two AION-301 infusions to adults with Stage 3 Chronic Kidney Disease (CKD). The trial will look at whether AION

Who is the study for?

Adults aged 35 to 75 with Stage 3 Chronic Kidney Disease can join this trial. They'll get two IV infusions of either the drug AION-301 or a placebo, plus oral vitamins for three months. Participants must commit to clinic visits over six months, possibly extending to two years.

What is being tested?

The study is testing the safety and effectiveness of AION-301 in reducing symptoms or slowing progression of CKD compared to a placebo. It involves receiving two IV infusions and taking oral vitamins while undergoing regular checkups and tests.

What are the potential side effects?

Potential side effects from AION-301 are not specified but will be monitored through adverse event reporting after each infusion. Side effects could range from mild reactions at the infusion site to more significant impacts on health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage 3 chronic kidney disease with a specific kidney function level and increased protein in my urine.

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I am between 35 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a recent heart attack, stroke, or uncontrolled high blood pressure.

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I haven't had any cancer except for skin cancer in the last 5 years.

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I have a history of blood clotting issues or only one kidney.

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My kidney disease is not caused by genetics, autoimmune diseases, recent severe injury, rapid worsening, very high blood sugar, or being significantly overweight.

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I have not abused alcohol, smoked, been pregnant, or breastfed in the last 6 months and do not plan to during the study.

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I have a history of atrial fibrillation.

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I have had an organ transplant or will have a kidney transplant soon.

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I do not have any active infections, significant lung problems, or allergies to the study drug.