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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBT-1 | Experimental | Single IV infusion prior to cardiac surgery |
|
| Placebo | Placebo Comparator | Single IV infusion prior to cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBT-1 | Drug | Intravenous administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Hierarchical composite of the following outcomes: death, incidence of AKI requiring dialysis, 30-day cardiopulmonary readmission, and intensive care unit (ICU days). | 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. | Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of the Number of Post-operative Complications | The number of the following post-operative complications per patient will be assessed:
| Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) or within 30-days post-discharge, as applicable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Lamy, MD | World Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Huntsville | Alabama | 35801 | United States | ||
| Research Site |
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Subjects will be randomized 1:1 to RBT-1 or placebo
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| Drug |
Intravenous administration |
|
| ICU Days | Days in ICU | Index hospitalization (ie, hospitalization post-cardiac surgery up to 60 days) |
| 30-day Cardiopulmonary Readmission Rates | Readmissions due to cardiopulmonary reasons | Within 30-days post-discharge |
| La Jolla |
| California |
| 92037 |
| United States |
| Research Site | San Francisco | California | 94107 | United States |
| Research Site | Stanford | California | 94305 | United States |
| Research Site | Washington D.C. | District of Columbia | 20011 | United States |
| Research Site | Atlantis | Florida | 33462 | United States |
| Research Site | Gainesville | Florida | 32608 | United States |
| Research Site | Athens | Georgia | 30606 | United States |
| Research Site | Atlanta | Georgia | 30342 | United States |
| Research Site | Fort Wayne | Indiana | 46804 | United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Indianapolis | Indiana | 46237 | United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Boston | Massachusetts | 02115 | United States |
| Research Site | Ann Arbor | Michigan | 48109 | United States |
| Research Site | Lansing | Michigan | 48879 | United States |
| Research Site | Midland | Michigan | 48670 | United States |
| Research Site | Royal Oak | Michigan | 48703 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | St Louis | Missouri | 63310 | United States |
| Research Site | Flushing | New York | 11355 | United States |
| Research Site | Raleigh | North Carolina | 27610 | United States |
| Research Site | Winston-Salem | North Carolina | 27157 | United States |
| Research Site | Cleveland | Ohio | 44106 | United States |
| Research Site | Toledo | Ohio | 43606 | United States |
| Research Site | Charleston | South Carolina | 29466 | United States |
| Research Site | Nashville | Tennessee | 37203 | United States |
| Research Site | Dallas | Texas | 75390 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Charlottesville | Virginia | 22903 | United States |
| Research Site | Kelowna | British Columbia | V1Y 0C5 | Canada |
| Research Site | Saint John | New Brunswick | E2L 4L2 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Research Site | Hamilton | Ontario | L8L 2X2 | Canada |
| Research Site | Kingston | Ontario | K7L 2V7 | Canada |
| Research Site | Montreal | Quebec | H1T 1C8 | Canada |
| Research Site | Montreal | Quebec | H2X 0C1 | Canada |
| Research Site | Montreal | Quebec | H4A 3J1 | Canada |
| Research Site | Montreal | Quebec | H4J 1C5 | Canada |
| Research Site | Québec | Quebec | G1V 4G5 | Canada |