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

NCT06021457 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2025-08-01

No results posted yet for this study

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). 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.

Conditions

  • Post-Operative Complications in Cardiac Surgery

Interventions

DRUG

RBT-1

Intravenous administration

DRUG

Placebo

Intravenous administration

Sponsors & Collaborators

  • Renibus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Andre Lamy, MD · World Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2025-06-17
Completion
2025-06-17
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06021457 on ClinicalTrials.gov