APX-115 for Acute Kidney Injury

Recruiting at 13 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

Trial Summary

What is the purpose of this trial?

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 oral dosing in patients with undergoing percutaneous coronary intervention. It is anticipated that approximately 280 patients will be randomized into the study in a 1:1 ratio to 400 mg APX-115 (Isuzinaxib hydrochloride) or placebo arm.

Eligibility Criteria

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.

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+