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NCT04564833 · ClinicalTrials.gov registry record · Phase 2

Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery

A Phase 2 study of AKI, sponsored by Renibus Therapeutics.

Completed
Registry status
Phase 2
Development phase
152
Enrollment target
20
Study locations

NCT04564833 is a Phase 2 study of AKI that has completed, run by Renibus Therapeutics. The registered enrollment target is 152 participants, above the 54-participant average among 4 other AKI trials with a reported enrollment target (181% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04564833, a Phase 2 study of AKI, has completed, sponsored by Renibus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
152 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.

Conditions Studied

AKI

Interventions

  • DRUG Placebo
  • DRUG Low Dose RBT-1
  • DRUG High Dose RBT-1

Study Locations (20)

California

  • Keck Hospital of USC - Los Angeles
  • Santa Barbara Cottage Hospital - Santa Barbara
  • Stanford University Medical Center - Stanford

New York

  • New York Presbyterian-Queens - Flushing
  • Columbia University Irving Medical Center - New York
  • Rochester General Hospital Center for Clinical Research - Rochester

Indiana

  • Indiana University Health Southern Indiana - Bloomington
  • Lutheran Medical Group - Fort Wayne

Michigan

  • McLaren Greater Lansing - Lansing
  • MyMichigan Medical Center - Midland

Alabama

  • Heart Center Research, LLC - Huntsville

Connecticut

  • Yale University School of Medicine - New Haven

District of Columbia

  • MedStar Health Research Institute, Inc. - Washington D.C.

Illinois

  • University of Chicago Hospital Anesthesia and Critical Care - Chicago

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2021-08-04
Est. Completion 2023-02-03
Phase Phase 2

Sponsor

Renibus Therapeutics

9 total trials

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What the Registry Record Tells You About NCT04564833

The ClinicalTrials.gov registry entry for NCT04564833 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 54-participant average among 4 other AKI trials with a reported enrollment target (181% higher). The listed sponsor is Renibus Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with AKI appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT04564833 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Indiana.

Frequently Asked Questions

What is clinical trial NCT04564833 about?

NCT04564833 is a clinical study titled "Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery". The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin \[SnPP\]/iron sucrose \[FeS\]) on preconditioning response biomarkers in subjects who are at risk for AKI following cardiac surgery.

What is the current status of trial NCT04564833?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 152 participants. The study started on 2021-08-04. Estimated completion is 2023-02-03.

What conditions does trial NCT04564833 study?

This clinical trial studies the following conditions: AKI.

What interventions are being tested in trial NCT04564833?

The interventions under investigation include: Placebo (DRUG), Low Dose RBT-1 (DRUG), High Dose RBT-1 (DRUG).

Who is sponsoring clinical trial NCT04564833?

This trial is sponsored by Renibus Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04564833 being conducted?

This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.