Contrast Induced NephropathyPhase 4NCT00292487
Patients With Renal Impairment Undergoing CT
A Phase 4 study testing Iopamidol 370 mgI/mL in people with Contrast Induced Nephropathy, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT… 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?
- Iopamidol 370 mgI/mL
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Feb 2006
- Phase
- Phase 4
- 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
- referred for MDCT of liver or peripheral CTA
- stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min
Who cannot join
- unstable renal function
- required prophylactic drugs to receive contrast (other than hydration)
- uncontrolled diabetes
- currently on dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Bracco Diagnostics, Inc
Princeton, New Jersey, 08543
About this study
Official title: Isovue and Visipaque in Renally Impaired Patients Undergoing CT
The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.
- Conditions
- Contrast Induced Nephropathy
- Being tested
- Iopamidol 370 mgI/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopamidol 370 mgI/mLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in SCr at 48-72 hours post dose
Secondary outcomes (3)
Compare incidence of delayed hypersensitivity type reactions
Compare changes in heart rate
Compare efficacy of key vessels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startNov 2004
- Primary completionFeb 2006
- Study completionFeb 2006
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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie Morris, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292487
- Sponsor's protocol ID
- IOP107
- Status last verified
- Aug 2006
- First submitted
- 14 Feb 2006
- Last updated
- 8 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isovue and Visipaque in Renally Impaired Patients Undergoing CT
- ClinicalTrials.gov ID
- NCT00292487
- Acronym / sponsor ID
- IOP107
- Conditions
- Contrast Induced Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 16 Feb 2006 (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.
The purpose of the study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue or Visipaque in patients with mild to moderate renal impairment who undergo a clinically indicated IV contrast-enhanced (multidetector computed tomography) MDCT of the liver or MDCT angiography of the lower extremities. Serum Creatinine (SCr) will be measured before and up to 48-72 hours post dose.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred for MDCT of liver or peripheral CTA
- stable baseline SCr of 1.5 - 2.5 mg/dL and/or calculated CrCl of 10-60 mL/min
Key exclusion criteria (4 listed)
- unstable renal function
- required prophylactic drugs to receive contrast (other than hydration)
- uncontrolled diabetes
- currently on dialysis
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 |
|---|---|---|
| Iopamidol 370 mgI/mL | Drug | – |
Primary outcome
Increase in SCr at 48-72 hours post dose
3 secondary outcomes
Compare incidence of delayed hypersensitivity type reactions
Compare changes in heart rate
Compare efficacy of key vessels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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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.
Marie Morris study director
Bracco Diagnostics, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iopamidol 370 mgI/mL in people with Contrast Induced Nephropathy, run by Bracco Diagnostics, Inc at 1 site 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increase in SCr at 48-72 hours post dose. 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 8 Feb 2012.