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

Primary Purpose

Post-Operative Complications in Cardiac Surgery

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RBT-1
Placebo
Sponsored by
Renibus Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Operative Complications in Cardiac Surgery focused on measuring Cardiac Surgery, CABG, Valve, Cardiopulmonary Bypass, Preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, ≥18 years of age at Screening. Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery. If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation. 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. Willingness to comply with all study-related procedures and assessments. Exclusion Criteria: Surgery planned to occur <24 hours from the start of study drug infusion. Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening. Surgery to be performed without CPB. Chronic kidney disease (CKD) requiring dialysis. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low. Cardiogenic shock or requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP). Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin. Known or suspected sepsis at time of Screening. Asplenia (anatomic or functional). History of hemochromatosis, iron overload, or porphyria. Known hypersensitivity or previous anaphylaxis to SnPP or FeS. Female subject who is pregnant or breastfeeding. Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.

Sites / Locations

  • New York Presbyterian-QueensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RBT-1

Placebo

Arm Description

Single IV infusion prior to cardiac surgery

Single IV infusion prior to cardiac surgery

Outcomes

Primary Outcome Measures

Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, days in ICU, and 30-day cardiopulmonary readmission
The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.

Secondary Outcome Measures

Composite of the Number of Post-operative Complications
The number of the following post-operative complications per patient will be assessed: Death AKI requiring dialysis >3 days in ICU >24 hours on ventilator 30-day cardiopulmonary readmission Need for blood transfusion during index hospitalization New-onset atrial fibrillation during index hospitalization
ICU Days
Days in ICU
30-day Cardiopulmonary Readmission Rates
Readmissions due to cardiopulmonary reasons

Full Information

First Posted
August 17, 2023
Last Updated
October 19, 2023
Sponsor
Renibus Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06021457
Brief Title
Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Reducing the Risk of Post-Operative Complications in Subjects Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renibus Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Complications in Cardiac Surgery
Keywords
Cardiac Surgery, CABG, Valve, Cardiopulmonary Bypass, Preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 1:1 to RBT-1 or placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RBT-1
Arm Type
Experimental
Arm Description
Single IV infusion prior to cardiac surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single IV infusion prior to cardiac surgery
Intervention Type
Drug
Intervention Name(s)
RBT-1
Intervention Description
Intravenous administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intravenous administration
Primary Outcome Measure Information:
Title
Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, days in ICU, and 30-day cardiopulmonary readmission
Description
The analysis will be based on a "win ratio," which uses the Finkelstein-Schoenfeld method wherein all RBT-1 patients are paired with all placebo patients; each pair is declared to be a win for RBT-1, a win for placebo, or a tie, based on the hierarchical composite. The win ratio is the ratio of the number of wins for RBT-1 divided by the number of wins for placebo.
Time Frame
Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
Secondary Outcome Measure Information:
Title
Composite of the Number of Post-operative Complications
Description
The number of the following post-operative complications per patient will be assessed: Death AKI requiring dialysis >3 days in ICU >24 hours on ventilator 30-day cardiopulmonary readmission Need for blood transfusion during index hospitalization New-onset atrial fibrillation during index hospitalization
Time Frame
Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable
Title
ICU Days
Description
Days in ICU
Time Frame
Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days)
Title
30-day Cardiopulmonary Readmission Rates
Description
Readmissions due to cardiopulmonary reasons
Time Frame
Within 30-days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, ≥18 years of age at Screening. Planned to undergo non-emergent CABG and/or cardiac valve surgery requiring CPB; non-emergent surgery must allow for study drug infusion ≥24 but ≤48 hours prior to surgery. If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or hysterectomy or is at least 1 year postmenopausal) for the duration of their study participation. 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. Willingness to comply with all study-related procedures and assessments. Exclusion Criteria: Surgery planned to occur <24 hours from the start of study drug infusion. Presence of acute organ dysfunction (AKI, acute decompensated heart failure, acute respiratory failure, stroke, etc) as assessed by the Investigator at the time of Screening. Surgery to be performed without CPB. Chronic kidney disease (CKD) requiring dialysis. Hypokalemia and/or hypomagnesemia within 24 hours prior to study drug infusion; electrolytes can be replenished if low. Cardiogenic shock or requirement for inotropes, vasopressors, or other mechanical devices, such as intra-aortic balloon pump (IABP). Known history of cancer within the past 2 years, except for carcinoma in situ of the cervix or breast, early-stage prostate cancer, or adequately treated non-melanoma cancer of the skin. Known or suspected sepsis at time of Screening. Asplenia (anatomic or functional). History of hemochromatosis, iron overload, or porphyria. Known hypersensitivity or previous anaphylaxis to SnPP or FeS. Female subject who is pregnant or breastfeeding. Participation in a study involving an investigational drug or device within 30 days prior to study drug infusion. In the opinion of the Investigator, for any reason, the subject is an unsuitable candidate to receive RBT-1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayla Rasmussen
Phone
443-569-9228
Email
arasmussen@renibus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Lamy, MD
Organizational Affiliation
World Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian-Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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