Renal Assist Device for Kidney Failure

(GRADIENT Trial)

Overseen By Alencia Washington, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: 3ive Labs

Disqualifiers: Immunosuppression, Active infections, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 30

Duration: Up to 72 hours

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the JuxtaFlow® Renal Assist Device can protect kidney function in patients with kidney issues undergoing heart surgery. The device uses gentle suction to support the kidneys during and after surgery, potentially reducing complications and improving recovery. Participants must have a diagnosis of kidney problems and be scheduled for specific heart surgeries, such as bypass or valve procedures.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could improve surgical outcomes for those with kidney issues.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the JuxtaFlow® Renal Assist Device is safe for patients with renal insufficiency?

Research shows that the JuxtaFlow Renal Assist Device helps protect the kidneys during heart surgery. Previous studies have examined the device's safety and effectiveness, and the results are encouraging. The device appears safe and effective in supporting the kidneys during surgery.

Importantly, these studies have not identified any serious safety issues, suggesting that patients tolerate the device well. Trials are ongoing as researchers continue to gather more information about the device’s safety and effectiveness. For now, it seems a promising option for those concerned about their kidneys during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The JuxtaFlow® Renal Assist Device is unique because it introduces a new approach to treating kidney failure by using controlled negative pressure directly on the kidneys. Unlike standard treatments, which often involve dialysis or medication, this device targets the renal pelvis with mild suction, potentially boosting kidney function more directly and effectively. Researchers are excited about this method because it offers a novel way to support kidney recovery, possibly leading to quicker improvements in patients' conditions while reducing reliance on traditional dialysis.

What evidence suggests that the JuxtaFlow® Renal Assist Device is effective for kidney failure?

Research has shown that the JuxtaFlow® Renal Assist Device (RAD), which participants in this trial may receive, can help protect kidney function during heart surgery. Early findings suggest it supports the kidneys' ability to filter blood by using gentle suction to reduce stress. This may protect kidney cells, lower the risk of oxygen shortages, and help the kidneys handle future stress. Although more data is needed, early results are promising for those with kidney concerns during surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Evelio Rodriguez, MD

Principal Investigator

Ascension Healthcare

Are You a Good Fit for This Trial?

This trial is for patients with kidney problems who are about to have heart surgery using a heart-lung machine. They should be at risk of their kidney issues getting worse after the operation. There's no detailed list here, but typically, people can't join if they're too sick for the surgery or have conditions that could mess up the study results.

Inclusion Criteria

I am scheduled for heart surgery involving bypass or valve repair.

Signed and dated informed consent

I am between 22 and 85 years old.

Exclusion Criteria

Evidence of current hydronephrosis

Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator

I do not have an ongoing infection in my bloodstream or heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the JuxtaFlow Renal Assist Device treatment for up to 72 hours peri-operatively

Up to 72 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of serum creatinine and eGFR changes

30 days

Regular assessments up to 30 days post-surgery

Long-term Follow-up

Participants are monitored for long-term outcomes such as hospital readmission and mortality

1 year

What Are the Treatments Tested in This Trial?

Interventions

• JuxtaFlow® Renal Assist Device

Trial Overview The JuxtaFlow Renal Assist Device (RAD) is being tested. It's supposed to help kidneys filter blood better during and after heart surgery by gently pulling fluid through them. This might protect kidneys from damage when they're under stress from the operation.

How Is the Trial Designed?

Group I: Renal Assist Device Experimental Treatment 1 Intervention

Subjects randomized to the Treatment group will receive up to 72 hours of controlled negative pressure (-15mmHg) into the renal pelvis of each kidney. Treatment will be discontinued when the subject is transferred out of critical care after at least 24 hours of treatment. A standard bladder catheter (i.e. Foley) will also be placed for bladder urine collection peri-operatively for up to 72 hours.

Group II: Standard of Care Active Control 1 Intervention

A standard bladder catheter (i.e. Foley) will be placed for bladder urine collection peri-operatively for up to 72 hours while in critical care. No JuxtaFlow catheters will be placed in control subjects.

Who Is Running the Clinical Trial?

3ive Labs

Lead Sponsor

Trials

2

Recruited

20+

RQM+

Industry Sponsor

Trials

1

Recruited

430+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07017933

NCT07017933 | Groundbreaking Renal Assist Device ... By supporting renal function, specifically during the acute stress of CPB, JuxtaFlow holds promise to protect nephron function, decrease renal hypoxia, and ...

2. renalinterventions.net renalinterventions.net/roivios-unveils-promising-new-clinical-data-on-the-juxtaflow-renal-assist-device-at-sts-2024-perioperative-care-meeting/

Roivios unveils promising new clinical data on the ... The study aimed to evaluate the safety and feasibility of the JuxtaFlow RAD, a novel device designed to sustain or enhance renal function immediately following ...

3. biospace.com biospace.com/press-releases/roivios-unveils-promising-new-clinical-data-on-the-juxtaflow-renal-assist-device-rad-at-the-society-of-thoracic-surgeons-sts-perioperative-care-meeting-in-philadelphia

Roivios Unveils Promising New Clinical Data on the ... Our lead product, the JuxtaFlow Renal Assist Device (RAD), is designed to preserve kidney function and offer a proactive approach to managing ...

4. prnewswire.com prnewswire.com/news-releases/fda-grants-ide-approval-for-the-pivotal-trial-of-the-juxtaflow-renal-assist-device-rad-302336698.html

FDA Grants IDE Approval for the Pivotal Trial of ... JuxtaFlow RAD is an innovative device designed to potentially improve kidney function during times of acute stress. By applying a gentle suction ...

5. ctv.veeva.com ctv.veeva.com/study/renal-assist-device-rad-for-patients-with-renal-insufficiency-undergoing-cardiac-surgery

Renal Assist Device (RAD) for Patients ... - ClinicalTrials.Veeva The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05990660/renal-assist-device-rad-for-patients-with-renal-insufficiency-undergoing-cardiac-surgery

Renal Assist Device (RAD) for Patients With ... The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System ...