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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

ANX-042 Aim 1 Trial 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.Check my eligibility

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.See study design

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.

ANX-042 Aim 1 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

ANX-042 Aim 1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

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

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Glomerular Filtration Rate

Secondary outcome measures

Change in Blood Pressure

Change in Renin-angiotensin-aldosterone system (RAAS)

Change in Sodium Excretion

+3 more

ANX-042 Aim 1 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,479 Total Patients Enrolled

35 Trials studying Heart Failure

7,826 Patients Enrolled for Heart Failure

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,767,080 Total Patients Enrolled

72 Trials studying Heart Failure

1,021,968 Patients Enrolled for Heart Failure

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,582 Total Patients Enrolled

206 Trials studying Heart Failure

677,388 Patients Enrolled for Heart Failure

Media Library

ANX-042 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT03019653 — Phase 1

Heart Failure Research Study Groups: Placebo first, then ANX-042, ANX-042 first, then Placebo

Heart Failure Clinical Trial 2023: ANX-042 Highlights & Side Effects. Trial Name: NCT03019653 — Phase 1

ANX-042 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03019653 — Phase 1

Frequently Asked Questions

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

Is access to this experiment accessible for participants at the moment?

"Based on the information posted to clinicaltrials.gov, this trial is not in search of participants at present. Initially published on January 1st 2017 and last modified February 23rd 2022, no further recruitment is being carried out for now; however there are 855 other trials presently enrolling patients."

Answered by AI

Are adolescents allowed to participate in this research endeavor?

"The parameters of this clinical trial only accept patients between 18 and 85 years old. For those that are younger than 18, there are 28 studies available while 839 exist for elderly individuals over the age of 65."

Answered by AI

What are the eligibility criteria for those wishing to join this research?

"This clinical trial is recruiting sixty individuals enduring heart failure, aged 18 to 85. Besides matching this demographic criteria certain medications must be taken at a constant dose for 4 weeks prior to enrolment and not increased over the duration of the study; left ventricular ejection fraction must have been determined by echocardiography or nuclear scan within 48 months (though if more than 12 months ago hand-held ECHO screening will occur when consented); New york Heart Association classifications II and III should remain unchanged in 3 month preceding registration with no episode of decompensated Congestive heart failure in 6 months; finally calculated creatinine clearance"

Answered by AI

Is this treatment well tolerated by patients?

"Distinctly, the safety of this intervention is estimated to be a 1 on a scale from 1 to 3 since it is only in its initial Phase 1 trial stage and has limited evidence supporting efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of ANX-042 in Human Cardiorenal Syndrome

Paul M. McKie, M.D. 2017. "Safety and Efficacy of ANX-042 in Human Cardiorenal Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03019653.

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