Chronic Kidney DiseasesPhase 4NCT03119662
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
A Phase 4 study testing Visipaque in people with Chronic Kidney Diseases, run by GE Healthcare at 29 sites in 6 countries.
Trial summary
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Visipaque
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 8 Feb 2018to 19 Oct 2018
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Was ≥18 years of age at the time that written informed consent is obtained.
- Was male or is a nonpregnant, nonlactating female who is either surgically sterile or is postmenopausal. Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative pregnancy test at the Baseline Visit.
- Was an outpatient who has undergone successful EVAR and is scheduled for his/her next post-procedural imaging follow-up examination.
- Had previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.
- Had a documented diagnosis of stage III or IV CKD and stable renal function.
- Was able to provide written informed consent.
- Was able and willing to comply with all study procedures as described in the protocol.
Who cannot join
- Was pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.
- Was a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as judged by the investigator) has already been discovered.
- Was undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).
- Had a known or suspected history of immediate or delayed hypersensitivity to iodine or any iodinated contrast medium.
- Was using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 24 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure.
- Had been exposed to any intravascular iodinated contrast medium in the 7 days prior to the Baseline Visit.
Show all 16Show fewer
- Had congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis.
- Had Stage V CKD.
- Had a pre-existing requirement for renal dialysis.
- Had undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months before the index EVAR procedure or is scheduled to undergo PTRA during the study period.
- Had any clinically active, serious, life-threatening disease, medical, or significant psychiatric condition; has a life expectancy of less than 6 months; or is, in the Investigator's opinion, unsuitable for participation in the study for any reason.
- Had been enrolled in another clinical study within the 30 days prior to the Screening Visit or is planned to enroll in another clinical study within the duration of this study.
- Had been previously enrolled in this study.
- Was using i.v. vasopressor or inotropic medications.
- Had used nonsteroidal anti-inflammatory drugs (NSAIDs) or any nephrotoxic medication within 48 hours of the Baseline Visit or will do so within 72 hours after the CT procedure-with the exception of acetylsalicylic acid (Aspirin) at a dose of ≤100 mg daily (QD).
- Had been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
United States17 sites
University Hospital
Birmingham, Alabama, 35233
Boston University Medical Center/Boston Medical Center
Boston, Massachusetts, 02118
University of Vermont Medical Center
Burlington, Vermont, 05401
University of North Carolina at Chapel Hill Clinical Translational Research Center
Chapel Hill, North Carolina, 27599
UT Southwestern Medical Center
Dallas, Texas, 75390
Universal Axon Clinical Research, LLC
Doral, Florida, 33166
The Duluth Clinic, Ltd.
Duluth, Minnesota, 55805
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Alliance Research Centers
Laguna Hills, California, 92653
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
Norton Hospital
Louisville, Kentucky, 40202
: Aventiv Research Inc.
Mesa, Arizona, 85210
Mount Sinai West
New York, New York, 10019
Rhode Island Hospital
Providence, Rhode Island, 02903
University of South Florida - South Tampa Campus
Tampa, Florida, 33606
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Poland4 sites
Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu
Bytom, 41-902
Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1
Lublin, 20-081
Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
Poznan, 61-848
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Puerta del Mar
Cadiz, 11009
Hospital Universitario Son Espases
Palma, 07120
Canada2 sites
CRCHUM- CHUM Research Center
Montreal, H2X 0A9
St. Boniface General Hospital
Winnipeg, R2H 2A6
United Kingdom2 sites
St. George's Healthcare NHS Trust, St. George's Hospital
London, SW17 0QT
Royal Stoke University Hospital, Radiology Department
Stoke-on-Trent, ST4 6QG
About this study
Official title: Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults With Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled post-EVAR surveillance imaging.
Read the detailed description
GEHC has decided not to provide this detail
- Conditions
- Chronic Kidney Diseases
- Being tested
- Visipaque, Placebos
- Keywords
- Acute kidney injury (AKI), Acute kidney injury network (AKIN), Chronic kidney disease (CKD), Contrast-enhanced computed tomography (CECT), Endovascular Aneurysm Repair (EVAR), Iodixanol, Non-enhanced computed tomography (NECT), Serum creatinine (SCr)
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisipaqueDrug
100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque.
PlacebosDrug
100 mL saline, followed by a 10 mL saline flush.
| Study group | Role | What they receive |
|---|---|---|
| Visipaque™: Contrast-Enhanced Computed Tomography (CECT) | Experimental | Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination. Receives: Drug: Visipaque |
| Saline: Non-Enhanced Computed Tomography (NECT) | Placebo comparator | Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent computed tomography (CT) examination and supplemental non-contrast duplex ultrasonography imaging examination. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.
Measured: 48 hours post-baseline (Follow-up 1)
Secondary outcomes (5)
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.
Measured: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)
Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.
Measured: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria
Waikar's definitions of AKI: Stage 1: 0.3 mg/dL increase in SCr over 24 hours or a 0.5 mg/dL increase in SCr over 48 hours. Stage 2: 0.5 mg/dL increase in SCr over 24 hours or a 1.0 mg/dL increase in SCr over 48 hours. Stage 3: 1.0 mg/dL increase in SCr over 24 hours or a 1.5 mg/dL increase in SCr over 48 hours.
Measured: 48 hours post-baseline (Follow-up 1)
All Cause Mortality and Morbidity
Mortality (all cause death) and morbidity i.e. critical events.
Measured: From Baseline to Month 6
Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale
Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. Image quality/diagnostic confidence for all imaging studies was rated on a 5-point scale from 1 (poor) to 5 (excellent).
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start8 Feb 2018
- Primary completion13 Sep 2018
- Study completion19 Oct 2018
Why it stopped: The trial was discontinued due to a lower than anticipated recruitment rate. The decision has not been made due to any safety reasons.
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119662
- Sponsor's protocol ID
- GE-012-106
- Other IDs
- 2016-001668-13, 2016
- Status last verified
- Nov 2019
- First submitted
- 21 Mar 2017
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.
PubMed 29751980
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults With Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
- ClinicalTrials.gov ID
- NCT03119662
- Acronym / sponsor ID
- GE-012-106
- Conditions
- Chronic Kidney Diseases
- Keywords
- Acute kidney injury (AKI), Acute kidney injury network (AKIN), Chronic kidney disease (CKD), Contrast-enhanced computed tomography (CECT), Endovascular Aneurysm Repair (EVAR), Iodixanol, Non-enhanced computed tomography (NECT), Serum creatinine (SCr)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was discontinued due to a lower than anticipated recruitment rate. The decision has not been made due to any safety reasons.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled post-EVAR surveillance imaging.
Detailed description
GEHC has decided not to provide this detail
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visipaque™: Contrast-Enhanced Computed Tomography (CECT) | Experimental | Drug: VisipaqueParticipants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination. |
| Saline: Non-Enhanced Computed Tomography (NECT) | Placebo comparator | Drug: PlacebosParticipants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent computed tomography (CT) examination and supplemental non-contrast duplex ultrasonography imaging examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Was ≥18 years of age at the time that written informed consent is obtained.
- Was male or is a nonpregnant, nonlactating female who is either surgically sterile or is postmenopausal. Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative pregnancy test at the Baseline Visit.
- Was an outpatient who has undergone successful EVAR and is scheduled for his/her next post-procedural imaging follow-up examination.
- Had previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.
- Had a documented diagnosis of stage III or IV CKD and stable renal function.
Key exclusion criteria (16 listed)
- Was pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.
- Was a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as judged by the investigator) has already been discovered.
- Was undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).
- Had a known or suspected history of immediate or delayed hypersensitivity to iodine or any iodinated contrast medium.
- Was using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 24 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure.
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 |
|---|---|---|
| Visipaque100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque. | Drug | Visipaque™: Contrast-Enhanced Computed Tomography (CECT) |
| Placebos100 mL saline, followed by a 10 mL saline flush. | Drug | Saline: Non-Enhanced Computed Tomography (NECT) |
Primary outcome
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
Time frame: 48 hours post-baseline (Follow-up 1)
AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 μmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 μmol/L) with an acute increase of >=0.5 mg/dL (>=44 μmol/L) within 48 hours.
5 secondary outcomes
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
Time frame: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)
Time frame: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria
Time frame: 48 hours post-baseline (Follow-up 1)
All Cause Mortality and Morbidity
Time frame: From Baseline to Month 6
Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale
Time frame: Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29751980Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.
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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.
29 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Visipaque in people with Chronic Kidney Diseases, run by GE Healthcare at 29 sites in 6 countries.
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 7 inclusion and 16 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Poland, Spain, Canada, United Kingdom and 1 more country. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Dec 2019). 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?
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria (time frame: 48 hours post-baseline (Follow-up 1)). 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 NCT03119662, which also lists 1 linked publication.
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 17 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.