NCT06811805

Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI

Post-Marketing Clinical Follow Up Study to Further Assess the Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: CardioRenal Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC). Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines. For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery. Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first. Long-term follow up will be performed at 90 days post surgery.

Conditions

• AKI - Acute Kidney Injury
• Cardiac Surgery Associated - Acute Kidney Injury

Interventions

Type	Name	Description
DEVICE	RenalGuard Therapy	RenalGuard Therapy
OTHER	Standard of Care (SOC)	Standard of care

Timeline

• Start date: 2025-02-23
• Primary completion: 2027-12-31
• Completion: 2028-04-30
• First posted: 2025-02-06
• Last updated: 2026-01-23

Locations

8 sites across 5 countries: Belgium, Germany, Israel, Spain, Sweden