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Active, Not Recruiting

NCT Number: NCT06092970

An Evaluation of Patient Reported Outcomes and Clinical Outcomes

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Post-Operative Complications in Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Kelowna, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RBT-1

Drug

Intravenous administration

Placebo

Drug

Intravenous administration

Primary outcomes

  1. Evaluation

    Time frame: 12 Months Post-Cardiac Surgery

    To evaluate patient reported outcomes (PRO) using the EQ-5D questionnaire

  2. Evaluation

    Time frame: 12 Months Post-Cardiac Surgery

    The number of subjects with the following clinical outcomes will be reported

    Clinical Outcomes:

    • Chronic kidney disease (CKD) - new diagnosis
    • Acute kidney injury (AKI) or CKD requiring dialysis
    • Atrial fibrillation - new-onset
    • Death
    • Myocardial infarction (MI)
    • Non-fatal cardiac arrest
    • Readmission to hospital
    • Reoperation for coronary artery bypass graft (CABG) and/or valve dysfunction
    • Stroke

Sponsors and collaborators

Lead sponsor

Renibus Therapeutics, Inc.

Industry

Registry information

Official study title

Clinical Protocol REN-007E - Extension Study: An Evaluation of Patient Reported Outcomes and Clinical Outcomes Through 12 Months Post-Cardiac Surgery in Subjects Enrolled in Study REN-007

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2023
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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