Renal ImpairmentPhase 4CINOPSIS CTNCT00793182

Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography

A Phase 4 study testing Ioversol 320 mgI/mL and Iodixanol 320 mgI/mL in people with Renal Impairment, run by Guerbet at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Impairment
What is being tested?: Ioversol 320 mgI/mL and Iodixanol 320 mgI/mL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 13 sitesUnited States
Study dates: Jan 2009to Jun 2009
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

Males and females 18 years of age or older
Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a < 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
Subjects must provide written consent and agree to abide by the site and study requirements

Who cannot join

Subjects previously entered into this study
Subjects on dialysis
Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
Subjects in acute renal failure or have one or more known causes of acute renal failure
Subjects have known or suspected unstable renal function

Show all 11Show fewer

Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration
Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn
Subjects taking aminoglycosides
Subjects known to have an organ transplantation
Subjects have severe congestive heart failure (Class III-IV)

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Maine Research Associates
Auburn, Maine, 04210
UAB Hospital
Birmingham, Alabama, 35233
Geisinger Medical Center
Danville, Pennsylvania, 17822
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Methodist Medical Center of Illinois
Peoria, Illinois, 61602
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Wake Research Associates
Raleigh, North Carolina, 27612
University of Rochester Medical Center
Rochester, New York, 114642
Radiology LTD
Tucson, Arizona, 85711
Trinity Clinic
Tyler, Texas, 75701
Providence Hospital
Washington D.C., District of Columbia, 20017
Radiology Consultants, Inc.
Youngstown, Ohio, 44512

Other trials in United States

About this study

Official title: A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Optiray 320 mgI/mL and Visipaque 320 mgI/mL on Renal Function in Subjects With Stable Reduced Renal Function Undergoing Contrast-enhanced Computed Tomography

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Read the detailed description

Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.

Conditions: Renal Impairment
Being tested: Ioversol 320 mgI/mL, Iodixanol 320 mgI/mL
Keywords: Renal, Kidney, Contrast Induced Nephropathy
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ioversol 320 mgI/mLDrug
Also called Optiray
125 mL of Ioversol administered in the vein
Iodixanol 320 mgI/mLDrug
Also called Visipaque
125 mL of Iodixanol administered in the vein

Study groups in NCT00793182
Study group	Role	What they receive
1	Active comparator	Ioversol 320 mgI/mL Receives: Drug: Ioversol 320 mgI/mL
2	Active comparator	Iodixanol 320 mgI/mL Receives: Drug: Iodixanol 320 mgI/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Contrast-induced Nephropathy (CIN)
Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration.
For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.
Measured: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jun 2009

First posted19 Nov 2008 (estimated)
Study startJan 2009
Primary completionJun 2009
Study completionJun 2009

Why it stopped: Slow enrollment

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.
Other trials for Renal ImpairmentStudies 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 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00793182
Sponsor's protocol ID: 1323-07-872
Acronym: CINOPSIS CT
Status last verified: Feb 2019
First submitted: 17 Nov 2008
Last updated: 6 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

All Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized Study to Evaluate the Effects of Optiray 320 mgI/mL and Visipaque 320 mgI/mL on Renal Function in Subjects With Stable Reduced Renal Function Undergoing Contrast-enhanced Computed Tomography
ClinicalTrials.gov ID: NCT00793182
Acronym / sponsor ID: CINOPSIS CT / 1323-07-872
Conditions: Renal Impairment
Keywords: Renal, Kidney, Contrast Induced Nephropathy
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow enrollment
Enrolment: 6 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 19 Nov 2008 (estimated)
Results: Posted 29 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Ioversol 320 mgI/mLIoversol 320 mgI/mL
2	Active comparator	Drug: Iodixanol 320 mgI/mLIodixanol 320 mgI/mL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males and females 18 years of age or older
Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL)
Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded
Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a < 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks
Subjects must provide written consent and agree to abide by the site and study requirements

Key exclusion criteria (11 listed)

Subjects previously entered into this study
Subjects on dialysis
Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment
Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration
Subjects in acute renal failure or have one or more known causes of acute renal failure

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
Ioversol 320 mgI/mLAlso: Optiray125 mL of Ioversol administered in the vein	Drug	1
Iodixanol 320 mgI/mLAlso: Visipaque125 mL of Iodixanol administered in the vein	Drug	2

Primary outcome

Percentage of Patients With Contrast-induced Nephropathy (CIN)
Time frame: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration
Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.

Results and safety

Results posted to the registry on 29 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iodixanol	2	2
Ioversol	4	3

Primary outcome: Percentage of Patients With Contrast-induced Nephropathy (CIN)

Time frame: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration. Count of participants. Unit: Participants

Measure	Iodixanol n = 2	IoversoI n = 3
Value	0	0

Population analysed: One patient from the Ioversol arm was prematurely withdrawn just after contrast medium administration due to the discovery of a new brain mass. Consequently, no SCr measurement was performed for this patient and the primary outcome could not be analyzed.

Adverse events

Time frame: All adverse events occuring during the time from signing of informed consent to the conclusion of the study were recorded. Overall, the study duration ranged from 1 day to 86 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iodixanol	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Ioversol	1 of 4 (25%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): Due to the small number of patients enrolled, no statistical analyses were performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Renal Impairment

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant

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.

Eddie Darton, MD study director

Mallinckrodt

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ioversol 320 mgI/mL and Iodixanol 320 mgI/mL in people with Renal Impairment, run by Guerbet at 13 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 11 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 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 29 Sep 2017). 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?

Percentage of Patients With Contrast-induced Nephropathy (CIN) (time frame: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration). 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 NCT00793182.

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 6 Mar 2019.