Contrast Induced NephropathyPhase 3CIN-RGNCT01456013
Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients
A Phase 3 study testing RenalGuard Therapy and Standard Therapy in people with Contrast Induced Nephropathy, run by CardioRenal Systems, Inc. at 30 sites in United States.
Trial summary
Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Induced Nephropathy
- What is being tested?
- RenalGuard Therapy and Standard Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 326 participants
- Where
- 30 sitesUnited States
- Study dates
- Jan 2012to Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
- Subject is scheduled to undergo an elective catheterization procedure
- Hemodynamically stable
- At increased risk of developing CIN
- Subject has agreed to all follow-up testing.
Who cannot join
- 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.
- Subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
- Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
- Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
- Patient has severe anemia (hemoglobin < 8.0 g/dL) at screening
Show all 14Show fewer
- Has received contrast within 10 days of procedure or has a planned additional cardiac or renal or other major surgical procedure within the 7 day follow-up period.
- Has ruled in for a Serious Heart Attack within 48 hours of the planned procedure
- Has documented respiratory insufficiency as evidenced by an oxygen saturation of < 90% on room air assessed on day of procedure.
- Planned addition, discontinuation or dose adjustment of nephrotoxic drugs
- Subject has a known hypersensitivity to furosemide and/or the contrast agent being used.
- Subject is currently, plans, or has been enrolled in another clinical study involving use of an investigational drug or device within the prior 30 days.
- Subject is pregnant or breastfeeding.
- Subject is unable to provide informed consent.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Austin Heart Central
Austin, Texas, 78756
Johns Hopkins University
Baltimore, Maryland, 21218
St. John Research Institute
Bartlesville, Oklahoma, 74006
University of Alabama
Birmingham, Alabama, 35924
St. Elizabeth's Hospital
Brighton, Massachusetts, 02135
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Clearwater Cardiovascular
Clearwater, Florida, 33756
Advocate Good Samaritan
Downers Grove, Illinois, 60515
Cape Cod Healthcare
Hyannis, Massachusetts, 02601
University of Florida
Jacksonville, Florida, 32209
Abbott Northwestern
Minneapolis, Minnesota, 55407
Advocate Health
Naperville, Illinois, 65040
NYU Medical Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Columbia University
New York, New York, 10032
Montefiore Medical Center
New York, New York, 10467
Northern Michigan Hospital
Petoskey, Michigan, 49770
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Baylor Scott & White
Plano, Texas, 75093
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
Rex Hospital
Raleigh, North Carolina, 27607
Austin Heart Round Rock
Round Rock, Texas, 78681
St. Joseph Medical Center
Saint Charles, Missouri, 63301
Guthrie Medical Center
Sayre, Pennsylvania, 18840
Stony Brook University Medical Center
Stony Brook, New York, 11794
Torrance Medical Center
Torrance, California, 90505
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory
Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- RenalGuard Therapy, Standard Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalGuard TherapyDevice
Induced Diuresis with matched replacement
Standard TherapyDrug
Standard of care for patients at risk of CIN
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | Standard of care for patients at risk of CIN Receives: Drug: Standard Therapy |
| RenalGuard Therapy | Experimental | Induced Diuresis with Matched Replacement Receives: Device: RenalGuard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast Induced Nephropathy
Measured: 72 hours
Secondary outcomes (4)
Major Adverse Cardiac Events
Measured: 90 days
Mean peak increase in serum creatinine post contrast administration
Measured: 72 hours
Proportion of patients who develop CIN at 7 days post contrast administration
Measured: 7 days
Proportion of patients who maintain a rise in serum creatinine at 7 days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2018
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast Induced NephropathyStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioRenal Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Davidson, MD, Principal investigator, Northwestern UniversityRichard Solomon, MD, Principal investigator, University of VermontRoxana Mehran, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456013
- Sponsor's protocol ID
- RGS001D
- Acronym
- CIN-RG
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2011
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate RenalGuard® System Safety & Efficacy When Compared With Standard Care in the Prevention of Contrast Induced NephRopathy in the SettinG of a Catheterization Laboratory
- ClinicalTrials.gov ID
- NCT01456013
- Acronym / sponsor ID
- CIN-RG / RGS001D
- Conditions
- Contrast Induced Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 326 participants (actual)
- Lead sponsor
- CardioRenal Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contrast-Induced Nephropathy (CIN) can occur when patients with pre-existing kidney problems undergo procedures that use iodinated contrast media, such as cardiac catheterizations. RenalGuard Therapy was developed to enable the patient to clear the contrast out of their kidney before it can do significant damage. This study aims to enroll patients with increased risk of developing CIN who are scheduled for a cardiovascular catheterization. Patients will be randomized to either RenalGuard therapy or standard therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Drug: Standard TherapyStandard of care for patients at risk of CIN |
| RenalGuard Therapy | Experimental | Device: RenalGuard TherapyInduced Diuresis with Matched Replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant female equal or greater than the age of 18 years old and is able to provide informed consent.
- Subject is scheduled to undergo an elective catheterization procedure
- Hemodynamically stable
- At increased risk of developing CIN
- Subject has agreed to all follow-up testing.
Key exclusion criteria (14 listed)
- 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.
- Subject has been hospitalized or treated medically for any change in renal function over the past week (i.e. dialysis, etc.), or a significant change in renal function is noted at time of screening.
- Has documented severe Aortic Stenosis.(Note: Subjects who have undergone successful replacement or repair of their aortic valve are not excluded.)
- Currently has a known clinically significant electrolyte imbalance or clinically significant arrhythmias which compromise subject's hemodynamic state.
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 |
|---|---|---|
| RenalGuard TherapyInduced Diuresis with matched replacement | Device | RenalGuard Therapy |
| Standard TherapyStandard of care for patients at risk of CIN | Drug | Standard Therapy |
Primary outcome
Incidence of Contrast Induced Nephropathy
Time frame: 72 hours
4 secondary outcomes
Major Adverse Cardiac Events
Time frame: 90 days
Mean peak increase in serum creatinine post contrast administration
Time frame: 72 hours
Proportion of patients who develop CIN at 7 days post contrast administration
Time frame: 7 days
Proportion of patients who maintain a rise in serum creatinine at 7 days
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
Related trials for Contrast Induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
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.
Charles Davidson, MD principal investigator
Northwestern University
Richard Solomon, MD principal investigator
University of Vermont
Roxana Mehran, MD principal investigator
Icahn School of Medicine at Mount Sinai
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RenalGuard Therapy and Standard Therapy in people with Contrast Induced Nephropathy, run by CardioRenal Systems, Inc. at 30 sites in United States.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of Contrast Induced Nephropathy (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2023.