An Evaluation of Patient Reported Outcomes and Clinical Outcomes

Purpose

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

Condition

  • Post-Operative Complications in Cardiac Surgery

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.

Exclusion Criteria

  • Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study. - Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
RBT-1 Patients undergoing CABG, valve, or combined CABG/valve surgery
  • Drug: RBT-1
    Intravenous administration
Placebo Patients undergoing CABG, valve, or combined CABG/valve surgery
  • Drug: Placebo
    Intravenous administration

Recruiting Locations

Research Site
Huntsville, Alabama 35801

Research Site
San Francisco, California 94107

Research Site
Stanford, California 94305

Research Site
Washington, District of Columbia 20010

Research Site
Atlantis, Florida 33462

Research Site
Gainesville, Florida 32608

Research Site
Athens, Georgia 30606

Research Site
Atlanta, Georgia 30342

Research Site
Fort Wayne, Indiana 46804

Research Site
Indianapolis, Indiana 46202

Research Site
Indianapolis, Indiana 46237

Research Site
Kansas City, Kansas 66160

Research Site
Boston, Massachusetts 02115

Research Site
Ann Arbor, Michigan 48109

Research Site
Lansing, Michigan 48879

Research Site
Midland, Michigan 48670

Research Site
Royal Oak, Michigan 48073

Research Site
Rochester, Minnesota 55905

Research Site
Saint Louis, Missouri 63310

New York Presbyterian-Queens
Flushing, New York 11355

Research Site
Raleigh, North Carolina 27610

Research Site
Winston-Salem, North Carolina 27157

Research Site
Cleveland, Ohio 44106

Research Site
Toledo, Ohio 43606

Research Site
Nashville, Tennessee 37203

Research Site
Dallas, Texas 75390

Research Site
Houston, Texas 77030

Research Site
San Antonio, Texas 78229

Research Site
Charlottesville, Virginia 22903

More Details

NCT ID
NCT06092970
Status
Recruiting
Sponsor
Renibus Therapeutics, Inc.

Study Contact

Jennifer Paleveda
813-760-3975
jpaleveda@renibus.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center