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RBT-1 for Cardiac Surgery Complications
N/A
Recruiting
Research Sponsored by Renibus Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-cardiac surgery
Awards & highlights
Study Summary
This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery: Patient reported outcomes (PRO), using the EQ-5D questionnaire Clinical outcomes
Eligible Conditions
- Cardiac Surgery Complications
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-cardiac surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-cardiac surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluation
Trial Design
2Treatment groups
Experimental Treatment
Group I: RBT-1Experimental Treatment1 Intervention
Patients undergoing CABG, valve, or combined CABG/valve surgery
Group II: PlaceboExperimental Treatment1 Intervention
Patients undergoing CABG, valve, or combined CABG/valve surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
RBT-1
2019
Completed Phase 1
~60
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Who is running the clinical trial?
Renibus Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
708 Total Patients Enrolled
Frequently Asked Questions
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