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ANX-042 for Cardiorenal Syndrome (ANX-042 Aim 1 Trial)

Phase 1

Waitlist Available

Led By Paul M McKie

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Calculated creatinine clearance of equal or less than 89 ml/min and greater than 20 ml/min, using the Modification of Diet in Renal Disease (MDRD) formula assessed within the past 48 months and a confirmatory calculated creatinine clearance equal or less than 89 ml/min and greater than 20 ml/min at the time of enrollment.

Be older than 18 years old

Must not have

Myocardial infarction within 6 months of screening

Female subject who is pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will help researchers understand how well a new drug works to improve kidney and hormonal function in patients with heart failure and kidney dysfunction.

Who is the study for?

This trial is for patients with heart failure and kidney dysfunction, specifically those with a left ventricular ejection fraction of 40% or less and creatinine clearance between 20-89 ml/min. Participants must have stable heart symptoms and not be on dialysis or have had recent severe cardiovascular issues.

What is being tested?

The study tests ANX-042's effects on kidney and hormonal functions in patients with cardiorenal syndrome versus a placebo. It aims to determine the safety and efficacy of this new drug in improving these conditions.

What are the potential side effects?

While specific side effects are not listed, potential risks may include typical drug reactions such as allergic responses, gastrointestinal disturbances, changes in blood pressure or electrolytes, fatigue, dizziness, or other organ-related inflammation.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine clearance, is between 20 and 89 ml/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack in the last 6 months.

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I am currently pregnant or breastfeeding.

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I have been on dialysis recently or might need it during the study.

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I was born with a serious heart condition.

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I have not had a stroke or significant brain blood flow issues in the last 3 months.

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I have a serious heart valve problem or other specific heart conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Active Control

Group I: Placebo first, then ANX-042Active Control2 Interventions

In the first intervention period the subjects will receive placebo. There will be a 3 week washout period. In the second intervention period, the subjects will receive an infusion of ANX-042.

Group II: ANX-042 first, then PlaceboActive Control2 Interventions

In the first intervention period the subjects will receive an infusion of ANX-042. There will be a 3 week washout period. In the second intervention period, the subjects will receive an infusion of placebo

0 / 7Eligibility criteria met