APX-115 for Acute Kidney Injury

Recruiting at 25 trial locations

Overseen By Aptabio Therapeutics Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Aptabio Therapeutics, Inc.

Must not be taking: CYP substrates, UGT inhibitors

Disqualifiers: Pregnancy, ESRD, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 1 week

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Isuzinaxib (APX-115) to determine its safety and effectiveness for Contrast Induced Acute Kidney Disease, a kidney injury that can occur after certain heart procedures. Participants will receive either the new treatment or a placebo (a pill with no active medication) for comparison. Individuals with coronary artery disease who plan to undergo coronary angiography (a heart procedure using X-ray imaging) may be suitable candidates. The trial aims to assess whether this new treatment can protect the kidneys during these procedures. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications that affect specific enzymes and transporters before enrolling. Your current medications will need to be reviewed and approved by the medical team before you can start the study.

Is there any evidence suggesting that APX-115 is likely to be safe for humans?

Research has shown that Isuzinaxib (APX-115) may help prevent kidney damage. These studies suggest it can protect against issues like inflammation and tissue damage. Although researchers are still testing the treatment, early results indicate promising safety.

This is a Phase 2 study, meaning researchers have already checked the treatment for basic safety in people. This phase focuses on how well participants can tolerate it and its effectiveness for the specific condition under study. So far, no major safety issues have emerged. However, like any medicine, some mild side effects might occur.

Prospective trial participants should discuss any concerns or questions with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Isuzinaxib (APX-115) because it offers a new approach to treating acute kidney injury (AKI). Unlike traditional treatments that mainly focus on managing symptoms and supporting kidney function, Isuzinaxib targets the underlying mechanisms of kidney damage. This drug is designed to be taken orally and acts quickly, with the potential to show effectiveness in just five days. Its innovative mechanism of action sets it apart from standard care options, offering hope for a more direct and efficient treatment for AKI.

What evidence suggests that APX-115 might be an effective treatment for acute kidney injury?

Research has shown that Isuzinaxib (APX-115), which participants in this trial may receive, might alleviate kidney problems by reducing oxidative stress, a harmful process that can damage cells. In people with type 2 diabetes and chronic kidney disease, Isuzinaxib significantly lowered the amount of protein in their urine, indicating improved kidney function. Studies also suggest that APX-115 can protect against various types of kidney damage, such as inflammation and scarring. These findings indicate that Isuzinaxib could benefit those at risk of sudden kidney injury during certain medical procedures. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with coronary artery disease who are planning to undergo a heart procedure called percutaneous coronary intervention. They should have a risk of kidney problems, as shown by specific blood test results. Women able to have children and men must use birth control during the study. Participants need to understand the study's experimental nature and follow all procedures.

Inclusion Criteria

You understand the study and agree to take part in it.

You understand that this study is still being tested and are willing to follow the treatment plan, have blood tests, and other check-ups described in the study information.

I am willing to use birth control as required during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 400 mg APX-115 or placebo orally for 5 consecutive days

1 week

Daily visits for 5 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of kidney function and safety endpoints

12 weeks

Regular visits over 12 weeks

Long-term follow-up

Monitoring of long-term kidney function and safety endpoints

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Isuzinaxib (APX-115)
• Placebo

Trial Overview The trial is testing APX-115 (Isuzinaxib), believed to protect against kidney damage after heart procedures involving contrast dyes, versus a placebo. About 280 patients will be randomly assigned in equal parts to either receive APX-115 or a dummy pill without any active ingredients.

How Is the Trial Designed?

Group I: Isuzinaxib (APX-115) Experimental Treatment 1 Intervention

4 x Isuzinaxib 88 mg calculated as free base (4 x 100mg APX-115(Isuzinaxib hydrocloride) capsules as salt form) administered QD, orally, for 5 consecutive days

Group II: Placebo Placebo Group 1 Intervention

4 x Placebo capsules administered QD, orally, for 5 consecutive days

Who Is Running the Clinical Trial?

Aptabio Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

520+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05758896

Study of APX-115 in Contrast Induced Acute Kidney Injury ... This phase 2 study is to assess the safety and efficacy of APX-115 active doses in Contrast Induced Acute Kidney Disease compared to placebo following multiple ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05758896?intr=ISUZINAXIB%20HYDROCHLORIDE&aggFilters=studyType:int&viewType=Table&rank=1

Study of APX-115 in Contrast Induced Acute Kidney Injury ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. healio.com healio.com/news/nephrology/20221109/speaker-isuzinaxib-effective-in-patients-with-ckd-type-2-diabetes

Speaker: Isuzinaxib effective in patients with CKD, type 2 ... Isuzinaxib, a pan-NOX inhibitor modulating oxidative stress by Aptabio significantly reduced urine albumin-to-creatinine ratio in patients with type 2 diabetes ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5650335/

A novel pan-Nox inhibitor, APX-115, protects kidney injury ... APX-115 effectively prevented kidney injury such as albuminuria, glomerular hypertrophy, tubular injury, podocyte injury, fibrosis, and inflammation as well as ...

5. delveinsight.com delveinsight.com/blog/emerging-therapies-for-acute-kidney-injury-treatment

Promising Therapies for Acute Kidney Injury Treatment Acute Kidney Injury treatments are evolving with breakthrough therapies targeting root causes, offering hope for better patient outcomes.

6. withpower.com withpower.com/trial/phase-2-acute-kidney-injury-4-2023-1dba9

APX-115 for Acute Kidney Injury This phase 2 study is to assess the safety and efficacy of APX-115 active doses in Contrast Induced Acute Kidney Disease compared to placebo following ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=75830333-cffa-44f7-aa8f-fc1300f78d2d

isuzinaxib (APX-115) / AptaBio Delicious. January 18, 2024. Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI (clinicaltrials.gov) - P2 | N=280 ...