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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
AION-301 Infusion
Placebo Infusion
SouthCoast Research Center, Inc.
Miami, Florida, United States
RECRUITINGUniversity of Miami, Leonard M. Miller School of Medicine
Miami, Florida, United States
RECRUITINGNumber 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.
Time frame: From baseline through day 90
To assess the potential evidence of efficacy in participants by
The differences between groups in the proportion of patients with reduced proteinuria.
Time frame: From Baseline for up to 2 years
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).
Time frame: From Baseline for up to 2 years
To assess the potential evidence of efficacy in participants by
The impact of treatment on Quality of Life with the KDQOL-36 questionnaire.
Time frame: From Baseline for up to 2 years
KidneyIntelX Risk Profile
Changes in KidneyIntelX risk levels
Time frame: From baseline through 6 months
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