AION-301 for Chronic Kidney Disease
(UC-MSC-CKD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new treatment, AION-301, is safe and effective for individuals with Stage 3 Chronic Kidney Disease (CKD). Participants will receive either AION-301 or a placebo to assess the treatment's effectiveness in reducing CKD symptoms or slowing disease progression. Suitable candidates should have Stage 3 CKD and maintain a stable dose of kidney-related medications for at least three months. As a Phase 1 trial, this research seeks to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial requires that you continue taking your current medications for chronic kidney disease, like ACE inhibitors, ARBs, or SGLT2 inhibitors, as long as they are not contraindicated or not tolerated. Your medication dose must be stable for at least 3 months before the trial.
Is there any evidence suggesting that AION-301 is likely to be safe for humans?
Research shows that AION-301 is being tested for safety in people with Stage 3 Chronic Kidney Disease (CKD). In this ongoing study, participants receive two IV infusions of the treatment. Early results from similar studies indicate that AION-301 has generally been well-tolerated in other conditions, with few serious side effects.
Since this trial is in the early stages, researchers closely monitor for any negative reactions after the infusions. If the FDA had already approved AION-301 for another condition, it would suggest some level of safety. However, this trial is one of the first detailed tests in humans, so participants should be aware of potential unknown risks.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AION-301 for chronic kidney disease because it offers a novel approach compared to standard treatments like ACE inhibitors and ARBs, which mainly focus on controlling blood pressure and reducing proteinuria. AION-301 stands out due to its unique mechanism of action; it targets specific pathways involved in kidney inflammation and fibrosis, potentially slowing disease progression more effectively. Additionally, this treatment could provide a more comprehensive approach by addressing underlying causes of kidney damage rather than just managing symptoms.
What evidence suggests that AION-301 might be an effective treatment for Chronic Kidney Disease?
Research shows that AION-301, which participants in this trial may receive, might help people with Stage 3 Chronic Kidney Disease (CKD). Earlier studies found that it can ease symptoms or slow the disease's progression. AION-301 works by targeting specific areas related to kidney damage. Early results suggest it could improve kidney function and delay disease progression. However, more information is needed to confirm these effects.12467
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two infusions of AION-301 or placebo on two separate days (Day 0 and Day 4) and oral vitamins for 90 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on adverse events and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- AION-301
Find a Clinic Near You
Who Is Running the Clinical Trial?
AION Healthspan, Inc.
Lead Sponsor
George Clinical
Collaborator