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Small Molecule

Isuzinaxib (APX-115) for Acute Kidney Injury

Q: Is it possible for patients to enroll in this ongoing clinical trial?

According to the information available on clinicaltrials.gov, this trial is presently seeking participants. The study was initially posted on December 27th, 2023 and its most recent update occurred on January 15th, 2024.

Q: At how many distinct venues is this scientific experiment currently being conducted?

There are 14 participating centers for this trial, including Sarkis Clinical Trials in Ocala, <a href="https://www.withpower.com/clinical-trials/florida">Florida</a> <a href="https://www.withpower.com/clinical-trials/cardiovascular">Cardiovascular</a> Research in Hialeah, and Chonnam National University Hospital in Gwangju. Additionally, there are several other locations across different regions involved as well.

Q: What is the primary objective of this research endeavor?

The primary goal of this investigation, spanning from Day 0 to Day 84, is to evaluate safety endpoints through laboratory assessments. Secondary outcomes include the assessment of pharmacokinetic parameters such as steady state trough plasma concentration (Css,min), renal clearance (CLR), and peak concentration (Cmax, Tmax). These parameters will be evaluated using plasma and urine samples collected from a subset of subjects.

Q: To what extent does Isuzinaxib (APX-115) pose risks to individuals receiving treatment?

Based on the Power team's assessment, Isuzinaxib (APX-115) received a safety rating of 2. Since it is currently in Phase 2 trial, there is limited data supporting its safety but no evidence yet regarding efficacy.

Phase 2

Recruiting

Research Sponsored by Aptabio Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Risk of CKD evidenced by 30 mL/min/1.73m2 ≤ eGFR (Glomerular filtration rate) < 90 mL/min/1.73 m2 confirmed by local or central laboratory.

Diagnosed with coronary artery disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 and week 12

Awards & highlights

Study Summary

This trial is being conducted to test the safety and effectiveness of a drug called APX-115 in patients who develop kidney problems after a heart procedure. The study will involve about 280 patients who will

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects of APX-115 aren't listed here, but generally, participants might experience issues related to the medication or placebo they receive during the trial. These could range from mild reactions at the pill-taking site to more serious body-wide effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is reduced but not severely impaired.

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I have been diagnosed with coronary artery disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety endpoints: ECG

Safety endpoints: adverse event

Safety endpoints: labs

+2 more

Secondary outcome measures

Incidence rate of Acute kidney injury

Kidney function parameters: creatinine, BUN

Kidney function parameters: eGFR

+13 more

Other outcome measures

Biomarkers assessment

Composite PCI outcome

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Isuzinaxib (APX-115)Experimental Treatment1 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: PlaceboPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Aptabio Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

244 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for patients to enroll in this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, this trial is presently seeking participants. The study was initially posted on December 27th, 2023 and its most recent update occurred on January 15th, 2024."

Answered by AI

At how many distinct venues is this scientific experiment currently being conducted?

"There are 14 participating centers for this trial, including Sarkis Clinical Trials in Ocala, Florida Cardiovascular Research in Hialeah, and Chonnam National University Hospital in Gwangju. Additionally, there are several other locations across different regions involved as well."

Answered by AI

What is the primary objective of this research endeavor?

"The primary goal of this investigation, spanning from Day 0 to Day 84, is to evaluate safety endpoints through laboratory assessments. Secondary outcomes include the assessment of pharmacokinetic parameters such as steady state trough plasma concentration (Css,min), renal clearance (CLR), and peak concentration (Cmax, Tmax). These parameters will be evaluated using plasma and urine samples collected from a subset of subjects."

Answered by AI

To what extent does Isuzinaxib (APX-115) pose risks to individuals receiving treatment?

"Based on the Power team's assessment, Isuzinaxib (APX-115) received a safety rating of 2. Since it is currently in Phase 2 trial, there is limited data supporting its safety but no evidence yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI

2023. "Study of APX-115 in Contrast Induced Acute Kidney Injury in Subjects Undergoing PCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05758896.