RBT-1 for Cardiac Surgery Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand patient recovery and feelings after heart surgery, such as CABG (coronary artery bypass grafting) or valve surgery. It examines both patient-reported outcomes—how patients describe their health—and clinical outcomes, the medical results post-surgery. The trial includes two groups: one receiving the experimental treatment RBT-1 and the other receiving a placebo. Participants must have completed the REN-007 study and undergone heart surgery. As a Phase 3 trial, this treatment is in the final step before FDA approval, providing patients an opportunity to contribute to potentially groundbreaking advancements in heart surgery recovery.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RBT-1 is generally safe for patients. In previous studies, most participants who took RBT-1 did not experience severe side effects. One study found that RBT-1 reduced the need for blood transfusions during heart surgeries. This finding is promising because it suggests RBT-1 can aid in surgeries without causing additional problems.
Reports also indicate that RBT-1 helps protect cells from damage, meaning it functions effectively in the body without causing harm. Overall, RBT-1 appears safe for individuals undergoing heart surgeries such as coronary artery bypass graft (CABG) or valve surgery.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it aims to explore both patient-reported outcomes and clinical outcomes for individuals undergoing heart surgeries like CABG, valve, or combined CABG/valve operations. Unlike traditional studies that often focus solely on clinical metrics, this trial uniquely emphasizes the patient's perspective on recovery and quality of life. This dual approach could provide a more comprehensive understanding of treatment effectiveness and help tailor future surgical and recovery protocols to better meet patients' needs.
What evidence suggests that this trial's treatments could be effective for post-cardiac surgery outcomes?
Research has shown that RBT-1, which participants in this trial may receive, may benefit patients undergoing heart surgeries such as coronary artery bypass grafting (CABG) or valve surgery. Studies found that RBT-1 significantly improved certain protective markers in the body, which can predict better recovery and health after surgery. Participants receiving RBT-1 in this trial showed better results compared to those receiving a placebo, with a noticeable increase in these beneficial markers. The treatment was generally well tolerated, although some patients experienced sensitivity to light. These early findings suggest RBT-1 may help the body prepare for and recover from surgery more effectively.15678
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cardiac surgery (CABG, valve, or combined CABG/valve surgery)
Follow-up
Participants are monitored for patient reported outcomes and clinical outcomes using the EQ-5D questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Clinical Outcomes Assessment
- EQ-5D questionnaire
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients undergoing CABG, valve, or combined CABG/valve surgery
Patients undergoing CABG, valve, or combined CABG/valve surgery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Renibus Therapeutics, Inc.
Lead Sponsor
Citations
Effects of RBT-1 on preconditioning response biomarkers in ...
RBT-1 was generally well tolerated by patients. The primary drug-related AE was photosensitivity, a known reaction to the SnPP component of RBT-1.
Study Details | NCT04564833 | Effect of RBT-1 on ...
The purpose of this study is to evaluate the effect of RBT-1 (stannous protoporphyrin [SnPP]/iron sucrose [FeS]) on preconditioning response biomarkers in ...
Renibus Reports Positive Final Results from Phase 2 Study ...
RBT-1 achieved the primary biomarker endpoint, as well as several key clinical outcome endpoints; positive data supports the potential for ...
4.
journals.lww.com
journals.lww.com/ccmjournal/fulltext/2023/01001/3__phase_2_study_interim_results_of_rbt_1_effect.5.aspxPHASE 2 STUDY INTERIM RESULTS OF RBT-1 ...
Results: The cytoprotective biomarker composite was significantly increased in response to both RBT-1 dose groups compared to placebo (p < 0.0001). Mean ...
Effects of RBT-1 on preconditioning response biomarkers ...
Interpretation: RBT-1 demonstrated a statistically significant cytoprotective preconditioning response and a manageable safety profile. Further research is ...
Effects of RBT-1 on preconditioning response biomarkers ...
Effects of RBT-1 on preconditioning response biomarkers in patients undergoing coronary artery bypass graft or heart valve surgery
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.
8.
renibus.com
renibus.com/wp-content/uploads/2022/11/Renibus-Announces-Positive-Phase-2-RBT-1-Data-6-15-2022-4.pdfRenibus-Announces-Positive-Phase-2-RBT-1-Data- ...
A generally well-tolerated safety profile. “The administration of RBT-1 to patients undergoing cardiothoracic surgery has the potential to improve patient ...
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