NCT04999163: A Priori

Aortix Therapy for Perioperative Reduction of Kidney Injury

Terminated NA Results posted Last updated 12 November 2024

What this trial tests

NA trial testing Aortix System in Acute Kidney Injury in 20 participants. Terminated before completion.

Timeline

17 July 2022

Primary endpoint
22 August 2023

22 August 2023

Quick facts

Lead sponsor	Procyrion
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	17 July 2022
Primary completion	22 August 2023
Estimated completion	22 August 2023
Sites	5 locations across Australia

Drugs / interventions tested

• Aortix System

Conditions studied

• Acute Kidney Injury — all drugs for Acute Kidney Injury →

Sponsor

Procyrion — full company profile →

Who can join

21 and older, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Serious Adverse Events Related to Aortix Primary · Enrollment to 30 days post-surgery

The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.

Group	Value	95% CI
Aortix Arm	1
Aortix Arm	1
Aortix Arm	6

Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery Primary · Baseline to 72 hours post-surgery

The intention is to characterize the change in severity of acute kidney injury observed at 72 hours post-surgery using the KDIGO AKI staging criteria. AKI Stage as defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines defines the level of acute kidney injury with Stage 1 being the lowest level of kidney injury and Stage 3 being the most severe. None refers to no acute kidney injury.

Group	Value	95% CI
Aortix Arm	1
Non-Aortix Arm	7
Aortix Arm	4
Non-Aortix Arm	0
Aortix Arm	1
Non-Aortix Arm	0
Aortix Arm	1
Non-Aortix Arm	0

Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis. Primary · Aortix placement to 30 days post- surgery

Renal replacement therapy (RRT), ultrafiltration, and dialysis are three treatment options for subjects with severe acute kidney injury and serve as a measure of the degree of acute kidney injury experienced by each group. Any subject receiving any of these therapies prior to 30 days post surgery are counted in this analysis.

Group	Value	95% CI
Aortix Arm	1
Non-Aortix Arm	1

Effectiveness Primary · If discharged by day 30 post-surgery

Characterize the rate of 30-day post-surgery readmission due to worsening renal function

Group	Value	95% CI
Aortix Arm	0
Non-Aortix Arm	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from enrollment to 30-Days post surgery.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Aortix Arm

Serious: 8/8 (100%)

Deaths: 0/8

Non-Aortix Arm

Serious: 4/9 (44%)

Deaths: 0/9

Serious adverse events (12 terms)

Reaction	System	Aortix Arm	Non-Aortix Arm
Bleeding	Vascular disorders	—	—
Renal Injury	Renal and urinary disorders	—	—
Other	General disorders	—	—
Hemolysis, Transient, Major	Blood and lymphatic system disorders	—	—
Cardiogenic Shock	Cardiac disorders	—	—
Pericardial Effusion	Cardiac disorders	—	—
Vascular Injury	Vascular disorders	—	—
Psychiatric Episode	Psychiatric disorders	—	—
Anemia	Blood and lymphatic system disorders	—	—
Hypotension	Cardiac disorders	—	—
Gyn/GU Miscellaneous	Gastrointestinal disorders	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Aortix Arm	Non-Aortix Arm
Renal Injury	Renal and urinary disorders	—	—
Arrhythmia	Cardiac disorders	—	—
Bleeding Event	Vascular disorders	—	—
GI Miscellaneous	Gastrointestinal disorders	—	—
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	—	—
Other	General disorders	—	—

Most-reported serious reactions: Bleeding, Renal Injury, Other, Hemolysis, Transient, Major, Cardiogenic Shock, Pericardial Effusion, Vascular Injury, Psychiatric Episode.

Data from ClinicalTrials.gov NCT04999163 adverse events section.

Sponsor's own description

The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.