RBT-1 for Cardiac Surgery Complications

No longer recruiting at 41 trial locations

Overseen By Ayla Rasmussen

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Renibus Therapeutics, Inc.

Disqualifiers: Acute organ dysfunction, CKD dialysis, cancer, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RBT-1, a combination of stannic protoporphyrin and iron sucrose, to determine if it can reduce complications after heart surgery involving a heart-lung machine. People undergoing planned heart surgeries, such as bypass or valve surgeries, might be suitable candidates. The study will compare RBT-1 to a placebo (a non-active treatment) administered before surgery to assess its effectiveness. Participants will also aid researchers in understanding how RBT-1 moves through the body. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that RBT-1 is likely to be safe for humans?

Research has shown that RBT-1 may improve outcomes for patients undergoing heart surgery. In earlier studies, patients who received RBT-1 required fewer blood transfusions than those given a placebo. This finding suggests that RBT-1 could effectively manage blood during surgery, indicating a positive safety profile.

The current Phase 3 trial of RBT-1 is providing additional evidence of its safety. By this stage, researchers have already tested the treatment in smaller groups, offering insights into its tolerability and potential side effects. A treatment reaches this phase after demonstrating a reasonable level of safety in earlier trials.

Overall, while more data is forthcoming, current findings suggest that RBT-1 is generally well-tolerated in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for complications after cardiac surgery focus on managing symptoms or supporting recovery through established medications and techniques. But RBT-1 works differently by being administered as a single intravenous infusion right before surgery, potentially setting the stage for better recovery outcomes. This unique timing may enhance the body's resilience during and after surgery, reducing the likelihood of complications. Researchers are excited because, unlike other treatments that often require prolonged use, RBT-1 promises to make a significant impact with just one dose, streamlining the process and possibly improving overall recovery time.

What evidence suggests that RBT-1 might be an effective treatment for cardiac surgery complications?

Research shows that RBT-1, which participants in this trial may receive, might help reduce complications after heart surgery. RBT-1 acts as a "preconditioning" agent, addressing inflammation and oxidative stress that often occur post-surgery. In earlier studies, patients who received RBT-1 experienced fewer recovery issues. This suggests RBT-1 could be particularly beneficial for those undergoing heart surgery with a machine that temporarily takes over heart and lung functions. Although more information is pending, early results are promising for improving recovery. ^{1 2 5 6 7}

Who Is on the Research Team?

Andre Lamy, MD

Principal Investigator

World Health Research Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

I am using birth control or not having sex with a male partner unless I'm unable to have children.

Willingness to comply with all study-related procedures and assessments

Exclusion Criteria

Known hypersensitivity or previous anaphylaxis to SnPP or FeS

My surgery is scheduled within 24 hours after starting the study drug.

I am currently pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single IV infusion of RBT-1 or placebo prior to cardiac surgery

1 day

1 visit (in-person)

Index Hospitalization

Participants are monitored for post-operative complications during hospitalization

Up to 60 days

Follow-up

Participants are monitored for safety and effectiveness after discharge

30 days post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• RBT-1

Trial Overview 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.

How Is the Trial Designed?

Group I: RBT-1 Experimental Treatment 1 Intervention

Single IV infusion prior to cardiac surgery

Group II: Placebo Placebo Group 1 Intervention

Single IV infusion prior to cardiac surgery

RBT-1 is already approved in United States for the following indications:

Approved in United States as RBT-1 for:

• Reduction in risk of post-operative complications in patients undergoing cardiothoracic surgery

Who Is Running the Clinical Trial?

Renibus Therapeutics, Inc.

Lead Sponsor

Trials

8

Recruited

1,200+

Published Research Related to This Trial

In a study of 114 patients with preoperative iron deficiency anemia undergoing CABG surgery, the combination of intravenous iron sucrose and erythropoietin significantly reduced the need for blood transfusions compared to the control group.

The intervention also led to improved ferritin levels and shorter hospital stays, with no reported adverse events, indicating a safe and effective approach to managing anemia in cardiac surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Iron Sucrose and Erythropoietin on Transfusion Requirements in Patients with Preoperative Iron Deficiency Anemia Undergoing on-Pump Coronary Artery Bypass Graft. Jafari, S., Talasaz, AH., Salehiomran, A., et al.[2022]

A single dose of intravenous iron saccharate (Venofer) significantly increased ferritin levels and reticulocyte rates in pediatric patients after cardiac surgery compared to a control group, indicating improved iron status and potential for faster recovery from anemia.

The study suggests that intravenous iron may be more effective than oral iron therapy in addressing functional iron deficiency in the context of postoperative inflammation, enhancing the quality of recovery for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Post-haemodilution anaemia in paediatric cardiac surgery: benefit of intravenous iron therapy]. Hulin, S., Durandy, Y.[2018]

In a study of 86 patients with iron deficiency anemia undergoing off-pump coronary artery bypass grafting, preoperative treatment with intravenous ferric carboxymaltose significantly improved hematologic parameters, including hemoglobin and serum iron levels, compared to a placebo.

The use of intravenous ferric carboxymaltose also reduced the need for red blood cell and platelet transfusions without causing any serious adverse events, indicating it is a safe and effective strategy for stabilizing patients before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Preoperative Administration of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency Anemia after Off-Pump Coronary Artery Bypass Grafting: A Randomized Controlled Trial. Kim, HH., Park, EH., Lee, SH., et al.[2023]

The study involved 214 patients undergoing complex heart valve surgery, where intravenous iron isomaltoside 1000 was administered to assess its impact on reducing the need for blood transfusions post-surgery.

The trial aims to clarify how perioperative intravenous iron affects transfusion requirements and overall clinical outcomes, while also investigating the role of hepcidin in increasing hemoglobin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial. Lee, SH., Shim, JK., Soh, S., et al.[2019]

In a trial involving 60 non-anaemic patients undergoing cardiac surgery, a single dose of 1000 mg intravenous iron isomaltoside 1000 significantly improved haemoglobin levels one month after surgery compared to placebo, with average levels rising from 11.8 g/dl to 12.6 g/dl.

The treatment also resulted in a higher percentage of patients remaining non-anaemic (38.5% vs. 8.0% in the placebo group) without any significant differences in side effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron isomaltoside 1000 (Monofer®) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial). Johansson, PI., Rasmussen, AS., Thomsen, LL.[2018]

Citations

1. renibus.com renibus.com/renibus-reports-positive-final-results-from-phase-2-study-of-rbt-1-a-first-in-class-preconditioning-agent-for-patients-undergoing-cardiothoracic-surgery-at-the-american-association-for-thoracic-surg/

Renibus Reports Positive Final Results from Phase 2 Study ... Renibus reports positive final results from Phase 2 study of RBT-1, a first-in-class preconditioning agent for patients undergoing cardiothoracic surgery.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11794240/

RBT‐1, a “preconditioning” agent, mitigates syndecan‐ ... RBT-1, a “preconditioning” agent, has been shown to mitigate postoperative complications following cardiac surgeries.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/renibus-rbt-1-trial/

Renibus completes enrolment in trial of RBT-1 Renibus has completed subject enrolment for the Phase III PROTECT trial of RBT-1 in minimising post-operative risk in cardiac surgery.

4. renibus.com renibus.com/renibus-therapeutics-announces-completion-of-enrollment-in-protect-a-pivotal-phase-3-clinical-trial-of-rbt-1-to-reduce-the-risk-of-post-operative-complications-after-cardiac-surgery/

Topline results expected in Q3 2025 A pivotal Phase 3 trial evaluating the effect of RBT-1 on reducing the risk of post-operative complications in patients undergoing cardiac surgery.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00541-2/fulltext

Effects of RBT-1 on preconditioning response biomarkers ... RBT-1 has the potential to improve post-operative complications in cardiac surgery, as well as in other surgeries where inflammation, oxidative ...

6. jtcvsopen.org jtcvsopen.org/article/S2666-2736(24)00179-7/fulltext

RBT-1 reduces blood product utilization in patients ... In this Phase 2 study, patients undergoing CABG and/or valve surgery treated with RBT-1 required less blood transfusion/blood product use compared with placebo.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666273624001797

RBT-1 reduces blood product utilization in patients ... RBT-1 reduces blood product utilization in patients undergoing nonemergency coronary artery bypass grafting and/or valve surgery.