AION-301 for Chronic Kidney Disease

(UC-MSC-CKD Trial)

Overseen By Desa Rae E Stanton-Pastore, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AION Healthspan, Inc.

Must be taking: RAAS blockers, SGLT2 inhibitors

Must not be taking: Immunosuppressants, Monoclonal antibodies

Disqualifiers: Transplant, Malignancy, Autoimmune, others

Compensation: Varies

Number of Visits: 11

Duration: 13 weeks

36 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

I've been on a stable dose of RAAS and SGLT2 inhibitors for 3 months.

I agree to use birth control and not donate sperm during the study.

I am following local guidelines for contraception while participating in this study.

Exclusion Criteria

Proteinuria > 5000 or serum Albumin < 2.5 g/dl

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

13 weeks

2 visits (in-person) for infusions, additional visits for vitamin administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on adverse events and quality of life

6 months

Minimum of 9 visits (in-person), up to 12 visits over 24 months

What Are the Treatments Tested in This Trial?

Interventions

• AION-301

Trial Overview

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.

How Is the Trial Designed?

Group I: Group I Active Control 1 Intervention

AION-301

Group II: Group II Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

AION Healthspan, Inc.

Lead Sponsor

Trials

1

Recruited

40+

George Clinical

Collaborator

Trials

2

Recruited

90+

Published Research Related to This Trial

Early treatment of chronic kidney disease (CKD) is crucial for slowing its progression, particularly by targeting the renin-angiotensin-aldosterone system, especially the effects of angiotensin II (AII).

Combining angiotensin-converting enzyme inhibitors (ACEIs) with angiotensin receptor blockers (ARBs) offers enhanced renal protection and is more effective in reducing proteinuria compared to using either medication alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary effects of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in slowing the progression of chronic kidney disease. Ripley, E.[2010]

In a study involving 83 patients with advanced chronic kidney disease (CKD), adding aliskiren to an angiotensin II receptor blocker (ARB) did not improve hard renal endpoints, such as the need for dialysis or serum creatinine levels, over a 12-month follow-up period.

The findings suggest that dual blockade of the renin-angiotensin-aldosterone system with aliskiren and ARB does not provide additional benefits for CKD patients, indicating that this combination therapy should not be recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of add-on therapy of aliskiren to an angiotensin II receptor blocker on renal outcomes in advanced-stage chronic kidney disease: a prospective, randomized, open-label study. Soji, K., Doi, S., Nakashima, A., et al.[2018]

The International Consortium for Health Outcomes Measurement (ICHOM) developed a standardized set of patient-centered outcomes for chronic kidney disease (CKD) to enhance value-based health care, focusing on outcomes that matter most to patients, such as survival and hospitalization.

The process involved input from health professionals and patients, ensuring that key measures like health-related quality of life were included, which can help institutions monitor and improve the quality of CKD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease: A Report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. Verberne, WR., Das-Gupta, Z., Allegretti, AS., et al.[2019]

Aliskiren, the only direct renin inhibitor available for treating hypertension, has shown promise in reducing albuminuria in patients with diabetic nephropathy, indicating potential benefits for chronic kidney disease.

However, a large trial investigating aliskiren as an add-on treatment was terminated early due to a lack of beneficial effects and an increased frequency of side effects, highlighting safety concerns in its use for chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct renin inhibition in chronic kidney disease. Persson, F., Rossing, P., Parving, HH.[2021]

The SONG-CKD initiative aims to create a standardized set of core outcomes for clinical trials involving patients with chronic kidney disease (CKD) who do not yet require kidney replacement therapy, ensuring that important patient-relevant outcomes are consistently reported.

This process involves a systematic review, stakeholder interviews, and an international Delphi survey to reach consensus among patients, caregivers, and health professionals, ultimately enhancing the relevance and impact of CKD research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardised Outcomes in Nephrology - Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy. Evangelidis, N., Sautenet, B., Madero, M., et al.[2021]

Citations

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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 ...

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

Trial Overview The study is testing the safety and effectiveness of AION-301 in reducing symptoms or slowing progression of CKD compared to a placebo. It ...

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AION Healthspan Announces First Patient Treated in ...

The clinical trial, focused on Diabetic Nephropathy and other forms of Chronic Kidney Disease, is underway at the University of Miami.

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First use of KidneyIntelX in new CKD therapy trial

First patient treated in clinical trial of AION Healthspan`s novel investigational cell therapy, REJUVXLTM ... (AION-301), including helping ...

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firstwordpharma.com

firstwordpharma.com/story/5963426

AION Healthspan Announces First Patient Treated in ...

The first patient has now received both infusions as part of treatment in its ongoing Phase I/II first-in-human clinical trial of AION-301.

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First use of KidneyIntelX in new CKD therapy trial

Under the terms of the agreement, Renalytix will be responsible for determining KidneyIntelX risk levels in subjects enrolled in the study and ...