RBT-1 for Cardiac Surgery Complications

Recruiting at 37 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

454 Participants Needed

Trial Summary

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 RBT-1 (Stannic protoporfin/iron sucrose) safe for humans?

In a study involving patients undergoing cardiac surgery, the use of iron sucrose combined with erythropoietin showed no significant adverse events, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does the drug RBT-1 differ from other treatments for cardiac surgery complications?

RBT-1, which includes stannic protoporfin and iron sucrose, is unique because it combines these components to potentially address complications in cardiac surgery, whereas other treatments often focus on using iron supplements alone to manage anemia. This combination may offer a novel approach by targeting multiple pathways involved in surgery-related complications. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of RBT-1 on reducing the risk of post-operative complications in subjects undergoing cardiac surgery on cardiopulmonary bypass (CPB). A sub-study will also be conducted to evaluate the pharmacokinetic (PK) profile of a single administration of RBT-1 by means of a popPK approach in subjects scheduled to undergo cardiac surgery.

Research Team

Andre Lamy, MD

Principal Investigator

World Health Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. Switzerland 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. [2023]

2. Iran 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. [2022]

3. France pubmed.ncbi.nlm.nih.gov

[Post-haemodilution anaemia in paediatric cardiac surgery: benefit of intravenous iron therapy]. [2018]

4. England 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). [2018]

5. England 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. [2019]