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Safety and Efficacy of ANX-042 in Human Cardiorenal Syndrome

NCT03019653 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-15

No results posted yet for this study

Summary

The purpose of this study is to look at kidney function and hormonal function in patients with a history of heart failure and kidney dysfunction, and to see how the use of a new drug, ANX-042, affects those functions.

Conditions

Interventions

DRUG

ANX-042

The first 20 subjects will receive a dose 0.003 µg/kg/min by infusion, the next 20 subjects will receive a dose of 0.006 µg/kg/min, then the next 20 subjects will receive 0.01 µg/kg/min.

DRUG

Placebo

The pharmacy created a placebo for this study is sterile Dextrose (5%) solution (D5W) 0.9% Sodium Chloride for intravenous administration to match study drug.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Paul M McKie, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2024-09-13
Completion
2024-09-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03019653 on ClinicalTrials.gov