Acute Kidney InjuryA PrioriNCT04999163

Aortix Therapy for Perioperative Reduction of Kidney Injury

A study testing Aortix System in people with Acute Kidney Injury, run by Procyrion at 5 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Acute Kidney Injury
What is being tested?: Aortix System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 5 sitesAustralia
Study dates: 17 Jul 2022to 22 Aug 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have the following risk factor(s) for AKI prior to surgery:
Estimated glomerular filtration rate (eGFR) of ≥ 15 and < 30 ml/min/1.73m2, OR
eGFR ≥ 30 and < 60 ml/min/1.73m2 and ONE or more of the following:
Diabetes (regardless of cause) with metabolic, renal, ophthalmic, neurologic, circulatory, or other complications
Documented NYHA class III or IV heart failure within 1 year prior to enrollment
Left ventricular ejection fraction < 35%

Show all 11Show fewer

Hypertension with comorbid heart or kidney disease
Persistent Atrial Fibrillation
Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair
Age >21 years, willing and able to provide written informed consent.
-

Who cannot join

An eGFR of <15 ml/min/1.73m2 at enrollment
Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass
Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart)
Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT)
Endovascular procedure with ilio-femoral access >12F within previous 30 days
Severe Bleeding Risk (any of the following):

Show all 19Show fewer

Previous intracranial bleed such that the patient cannot safely use anticoagulation per the study requirements
Platelet count <75,000 cells/mm3
Uncorrectable bleeding diathesis or coagulopathy (e.g., INR ≥ 2 not due to anticoagulation therapy
Current endovascular stent graft in the descending aorta or either ilio-femoral vessels
Contraindicated Anatomy:
Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)]
Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath
Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification)
Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury
Known hypersensitivity or contraindication to study required medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol)
Positive pregnancy test if of childbearing potential
Participation in any other clinical investigation that is likely to confound study results or affect the study
-

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Australia5 sites

Royal Adelaide Hospital
Adelaide
Prince Charles Hospital
Brisbane
Princess Alexandra Hospital
Brisbane
Monash Health
Melbourne
Macquarie University
Sydney

Other trials in Australia

About this study

Read the detailed 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. Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant will be followed in the non-Aortix arm. Both arms will have the same visit schedule and data collection requirements with the exception of data pertaining to the Aortix system. Data will be reported for both groups.

Conditions: Acute Kidney Injury
Being tested: Aortix System
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Aortix SystemDevice
Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery who are at heightened risk of developing AKI.

Study groups in NCT04999163
Study group	Role	What they receive
Aortix Arm	Experimental	Subject receives the Aortix device. Receives: Device: Aortix System
Non-Aortix Arm	No intervention	Control Arm consists of subjects who choose not to receive the Aortix device or who do not meet the anatomical requirements to receive the Aortix device.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Serious Adverse Events Related to Aortix
The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.
Measured: Enrollment to 30 days post-surgery
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 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.
Measured: Baseline to 72 hours post-surgery
Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.
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.
Measured: Aortix placement to 30 days post- surgery
Effectiveness
Characterize the rate of 30-day post-surgery readmission due to worsening renal function
Measured: If discharged by day 30 post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 202222 Aug 2023

First posted10 Aug 2021
Study start17 Jul 2022
Primary completion22 Aug 2023
Study completion22 Aug 2023

Why it stopped: It has been decided that further enrollment in this study, as designed, will not be able to answer the proposed hypothesis of the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04999163
Sponsor's protocol ID: PVP054
Acronym: A Priori
Status last verified: Oct 2024
First submitted: 3 Aug 2021
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Kidney Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Aortix Therapy for Perioperative Reduction of Kidney Injury
ClinicalTrials.gov ID: NCT04999163
Acronym / sponsor ID: A Priori / PVP054
Conditions: Acute Kidney Injury
Study type: Interventional
Recruitment status: TerminatedReason stopped: It has been decided that further enrollment in this study, as designed, will not be able to answer the proposed hypothesis of the study.
Enrolment: 20 participants (actual)
Lead sponsor: ProcyrionIndustry (pharma, biotech, devices)
Collaborators: Procyrion Australia Pty Ltd
Study start: 17 Jul 2022 (actual)
Primary completion: 22 Aug 2023 (actual)
Study completion: 22 Aug 2023 (actual)
First posted: 10 Aug 2021 (actual)
Results: Posted 12 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Aortix Arm	Experimental	Device: Aortix SystemSubject receives the Aortix device.
Non-Aortix Arm	No intervention	–Control Arm consists of subjects who choose not to receive the Aortix device or who do not meet the anatomical requirements to receive the Aortix device.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Have the following risk factor(s) for AKI prior to surgery:
Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair
Age >21 years, willing and able to provide written informed consent.
-

Key exclusion criteria (19 listed)

An eGFR of <15 ml/min/1.73m2 at enrollment
Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass
Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart)
Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT)
Endovascular procedure with ilio-femoral access >12F within previous 30 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Aortix SystemAortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing cardiac surgery who are at heightened risk of developing AKI.	Device	Aortix Arm

Primary outcome

Number of Participants With Serious Adverse Events Related to Aortix
Time frame: Enrollment to 30 days post-surgery
The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery
Time frame: 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.
Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.
Time frame: 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.
Effectiveness
Time frame: If discharged by day 30 post-surgery
Characterize the rate of 30-day post-surgery readmission due to worsening renal function

Results and safety

Results posted to the registry on 12 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aortix Arm	11	8
Non-Aortix Arm	9	9

Primary outcome: Number of Participants With Serious Adverse Events Related to Aortix

Time frame: Enrollment to 30 days post-surgery. Count of participants. Unit: Participants

Measure	Aortix Arm n = 8
Bleeding (BARC 3b)	1
Hemolysis, Transient, Major	1
No Serious Related Adverse Events	6

Population analysed: All participants that had an attempted or successful Aortix device implant.

Primary outcome: Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery

Time frame: Baseline to 72 hours post-surgery. Count of participants. Unit: Participants

Measure	Aortix Arm n = 7	Non-Aortix Arm n = 9
No Change	1	7
From None to AKI Stage 1	4	0
From None to AKI Stage 2	1	0
From None to AKI Stage 3	1	0
From AKI Stage 1 to None	0	1
Missing Data	0	1

Population analysed: All participants who completed follow up in the study. 1 participant in the Aortix arm was excluded from analysis due to significant change in medical status.

Primary outcome: Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.

Time frame: Aortix placement to 30 days post- surgery. Count of participants. Unit: Participants

Measure	Aortix Arm n = 7	Non-Aortix Arm n = 9
Value	1	1

Population analysed: All participants who completed the study are included in this analysis. One patient in the Aortix Arm was excluded due to significant change in medical status.

Primary outcome: Effectiveness

Time frame: If discharged by day 30 post-surgery. Count of participants. Unit: Participants

Measure	Aortix Arm n = 7	Non-Aortix Arm n = 9
Value	0	0

Population analysed: Participants who completed the study are included in this analysis. One patient in the Aortix Arm is excluded from this analysis due to significant change in medical status.

Adverse events

Time frame: Adverse Events were collected from enrollment to 30-Days post surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aortix Arm	8 of 8 (100%)	6 of 8 (75%)	0 of 8
Non-Aortix Arm	4 of 9 (44.4%)	3 of 9 (33.3%)	0 of 9

Limitations and caveats (from the sponsor): Early termination of the study leading to small numbers of subjects analyzed. The non-Aortix group did not show the expected incidence of acute kidney injury during and following surgery and therefore a comparison between the groups could not be made. As a result study enrollment was stopped early and the study was terminated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acute Kidney Injury

Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Aortix System in people with Acute Kidney Injury, run by Procyrion at 5 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serious Adverse Events Related to Aortix (time frame: Enrollment to 30 days post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04999163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.