What is the mechanism of action of this treatment?

The most common treatments for prophylaxis of nephropathy, such as RenalGuard Therapy, work by enhancing the clearance of harmful agents from the kidneys. RenalGuard Therapy induces high urine output to flush out contrast media before it can cause significant damage. Other treatments like N-acetylcysteine reduce oxidative stress, and bicarbonate alkalinizes the urine to prevent free radical formation. These mechanisms are vital for protecting kidney function in at-risk patients, thereby preventing further renal damage and reducing the need for more invasive treatments.

What side effects are associated with this type of intervention?

Common treatments for the prophylaxis of nephropathy, particularly in the context of preventing contrast-induced nephropathy (CIN), include hydration protocols and the use of diuretics like furosemide. Side effects of these treatments can include electrolyte imbalances (such as hypokalemia or hyponatremia), dehydration, and potential worsening of kidney function if not carefully monitored. RenalGuard Therapy, which aims to clear contrast media from the kidneys, may also carry risks of fluid overload or imbalances if not properly managed. Overall, while these treatments are generally effective, they require careful monitoring to avoid adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at the prophylaxis of nephropathy, particularly in the context of preventing Contrast-Induced Nephropathy (CIN). These include hydration protocols and the use of medications such as N-acetylcysteine, which have been shown to reduce the risk of CIN by enhancing renal clearance of contrast agents. Additionally, the use of sodium bicarbonate infusions has been approved to alkalinize the urine and protect renal function. While these treatments differ in mechanism from RenalGuard Therapy, which actively facilitates the clearance of contrast media from the kidneys, they share the common goal of preventing nephropathy by mitigating the harmful effects of contrast agents.

What other types of research exist?

Promising alternatives to RenalGuard Therapy for the prophylaxis of nephropathy in 2024 include the use of sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as dapagliflozin, which have shown renal protective effects in patients with chronic kidney disease. Additionally, the use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) to manage blood pressure and reduce proteinuria can be beneficial. These therapies, combined with optimized supportive care including hydration and avoidance of nephrotoxic agents, represent effective strategies for reducing the risk of contrast-induced nephropathy.

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Device

RenalGuard Therapy for Kidney Disease (CIN-RG Trial)

Phase 3

Waitlist Available

Led By Richard Solomon, MD

Research Sponsored by CardioRenal Systems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Class 4 Congestive Heart Failure (CHF)or a documented left ventricular ejection fraction < 30%

Is anuric or has undergone renal replacement therapy within the past month, or has a known inability to have a Foley catheter placed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests RenalGuard Therapy, which helps patients with kidney problems quickly remove a special dye used in heart procedures to prevent kidney damage. It targets patients at high risk of kidney damage from the dye. The therapy works by speeding up dye removal from the kidneys.

Who is the study for?

This trial is for adults over 18 at risk of kidney damage from contrast media used in heart catheterizations. Participants must be stable, not pregnant, able to consent, and agree to follow-up tests. Exclusions include recent serious heart attack, allergies to specific drugs, severe heart failure or anemia, recent or upcoming surgeries involving contrast media.

What is being tested?

The study compares RenalGuard Therapy—a method that helps clear contrast agents from the kidneys—to standard therapy in preventing Contrast-Induced Nephropathy (CIN) during cardiovascular procedures.

What are the potential side effects?

Potential side effects may include reactions related to furosemide or the contrast agent used with RenalGuard Therapy. Standard therapy risks depend on the usual care provided but can involve kidney function changes due to the contrast agent.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart failure or my heart pumps less than 30% of the blood.

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I cannot produce urine, have had kidney replacement therapy recently, or cannot have a urinary catheter placed.

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I have been hospitalized or treated for kidney issues in the past week.

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I am unable to understand and give consent for treatment.

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I have a serious electrolyte imbalance or heart rhythm problem affecting my blood flow.

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My hemoglobin level is below 8.0 g/dL.

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My oxygen levels are below 90% without extra oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RenalGuard TherapyExperimental Treatment1 Intervention

Induced Diuresis with Matched Replacement

Group II: Standard TherapyActive Control1 Intervention

Standard of care for patients at risk of CIN

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prophylaxis of nephropathy, such as RenalGuard Therapy, work by enhancing the clearance of harmful agents from the kidneys. RenalGuard Therapy induces high urine output to flush out contrast media before it can cause significant damage. Other treatments like N-acetylcysteine reduce oxidative stress, and bicarbonate alkalinizes the urine to prevent free radical formation. These mechanisms are vital for protecting kidney function in at-risk patients, thereby preventing further renal damage and reducing the need for more invasive treatments.

Evidence-based emergency medicine review. Prevention of contrast-induced nephropathy in the emergency department.