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COMPLETED Phase 2

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

NCT04564833 · View on ClinicalTrials.gov ↗

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

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

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04564833

The ClinicalTrials.gov registry entry for NCT04564833 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renibus Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04564833 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04564833?

This trial is sponsored by Renibus Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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