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RBT-1 for Cardiac Surgery Complications

Phase 3

Recruiting

Led By Andre Lamy, MD

Research Sponsored by Renibus Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner for the duration of their study participation, unless the subject has had a vasectomy ≥6 months prior to infusion with study drug

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

Awards & highlights

Study Summary

This trial looks at if a drug can reduce the risk of complications after heart surgery.

Who is the study for?

Adults over 18, scheduled for non-emergency heart surgery with cardiopulmonary bypass, can join this trial. They must be willing to follow study procedures and use effective birth control. Exclusions include emergency surgeries within 24 hours, acute organ dysfunction, chronic kidney disease on dialysis, certain heart conditions, recent cancer (with exceptions), sepsis at screening time, specific blood disorders or allergies to the drug's components.Check my eligibility

What is being tested?

The trial is testing RBT-1's ability to lower post-surgery complications in patients having cardiac surgery using a bypass machine. A sub-study will also look into how the body processes RBT-1. Participants are randomly assigned to receive either RBT-1 or a placebo before their operation.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions related to iron compounds such as skin irritation or staining at the injection site and general symptoms like headache or nausea which are common in trials involving intravenous drugs.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am a male and will use birth control or abstain from sex during the study, unless I had a vasectomy over 6 months ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable

This trial's timeline: 3 weeks for screening, Varies for treatment, and index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, days in ICU, and 30-day cardiopulmonary readmission

Secondary outcome measures

30-day Cardiopulmonary Readmission Rates

Composite of the Number of Post-operative Complications

ICU Days

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RBT-1Experimental Treatment1 Intervention

Single IV infusion prior to cardiac surgery

Group II: PlaceboPlacebo Group1 Intervention

Single IV infusion prior to cardiac surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RBT-1

2019

Completed Phase 1

~60

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Renibus Therapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

708 Total Patients Enrolled

Andre Lamy, MDPrincipal InvestigatorWorld Health Research Institute

5 Previous Clinical Trials

19,322 Total Patients Enrolled

Frequently Asked Questions

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

How have safety assessments of RBT-1 been evaluated by medical professionals?

"The safety of RBT-1 received an assessment rating of 3, due to the accumulated evidence suggesting its efficacy and multiple rounds of tests verifying its security."

Answered by AI

Does this study have vacancies for participants?

"This clinical trial, which was initially published on October 17th 2023 is still looking for participants. The information presented on the website has been up to date as of October 19th 2023."

Answered by AI

How many participants will be involved in this trial?

"Affirmative. Clinicaltrials.gov indicates that this research endeavour, which was first uploaded on October 17th 2023, is actively recruiting participants. Approximately 400 patients are needed from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery

2023. "Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06021457.