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

Trial Summary

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.

What data supports the effectiveness of the drug AION-301 for chronic kidney disease?

Research on similar treatments, like the combination of aliskiren and angiotensin receptor blockers, shows they can reduce proteinuria (excess protein in urine), which is a sign of kidney damage. This suggests that AION-301 might also help in managing chronic kidney disease by potentially reducing proteinuria. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Japan 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. [2018]

2. United States 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Direct renin inhibition in chronic kidney disease. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2021]