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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
CIN-RG Trial Summary
This trial is testing a new therapy to help reduce kidney damage in patients undergoing cardiac catheterization. Patients at increased risk of CIN are enrolled to compare RenalGuard therapy to standard therapy.
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.Check my eligibility
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.See study design
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.
CIN-RG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Contrast Induced Nephropathy
Secondary outcome measures
Major Adverse Cardiac Events
Mean peak increase in serum creatinine post contrast administration
Proportion of patients who develop CIN at 7 days post contrast administration
+1 moreCIN-RG 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
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Who is running the clinical trial?
CardioRenal Systems, Inc.Lead Sponsor
2 Previous Clinical Trials
80 Total Patients Enrolled
Richard Solomon, MDPrincipal InvestigatorUniversity of Vermont
1 Previous Clinical Trials
112 Total Patients Enrolled
Charles Davidson, MDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
870 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot produce urine, have had kidney replacement therapy recently, or cannot have a urinary catheter placed.I have been hospitalized or treated for kidney issues in the past week.I am unable to understand and give consent for treatment.I have had a contrast agent or plan to have major surgery within the next week.I am planning changes to my medication that could affect my kidneys.I have severe heart failure or my heart pumps less than 30% of the blood.I am 18 or older and can give my consent.My heart and blood circulation are stable.I have a serious electrolyte imbalance or heart rhythm problem affecting my blood flow.I am scheduled for a planned catheterization procedure.My hemoglobin level is below 8.0 g/dL.I have been diagnosed with severe Aortic Stenosis.My oxygen levels are below 90% without extra oxygen.You have had a serious heart attack within 48 hours before the planned procedure.At a higher risk of developing cervical intraepithelial neoplasia (CIN).
Research Study Groups:
This trial has the following groups:- Group 1: Standard Therapy
- Group 2: RenalGuard Therapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any potential harm associated with RenalGuard Therapy?
"The safety of RenalGuard Therapy is rated highly at 3, as evidenced by the data collected in its Phase 3 clinical trial. Past evidence indicates that efficacy and security have been repeatedly demonstrated."
Answered by AI
Is there still opportunity to enroll in this research undertaking?
"Per the information displayed on clinicaltrials.gov, this study is not presently recruiting patients; however, it was first posted on January 1st 2012 and last updated February 15th 2023. Fortunately, there are 495 other trials actively in search of candidates at present."
Answered by AI
How many institutions are conducting this clinical trial?
"More than 30 institutions are currently involved in this clinical trail, including the University of Massachusetts in Worcester, Torrance Medical Centre and Abbott Northwestern located in Minneapolis. Additionally, there are over thirty other sites that have joined forces with these three medical centres."
Answered by AI
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