Kidney DiseasesPhase 4NCT00289614
Patients With Renal Impairment and Diabetes Undergoing Computed Tomography (CT)
A Phase 4 study testing Iopamidol 370 mgI/dL in people with Kidney Diseases, run by Bracco Diagnostics, Inc at 1 site in United States.
Trial summary
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Iopamidol 370 mgI/dL
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Apr 2007
- 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 contrast enhanced MDCT
- Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
- Diagnosed as having diabetes mellitus
Who cannot join
- Unstable renal function
- Unstable diabetes
- Concurrent administration of nephrotoxic drugs
- Undergoing dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Bracco Diagnostics, Inc.
Princeton, New Jersey, 08540
About this study
Official title: Patients With Renal Impairment and Diabetes Undergoing Computed Tomography
The main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.
- Conditions
- Kidney Diseases
- Being tested
- Iopamidol 370 mgI/dL
- Keywords
- contrast induced nephropathy
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopamidol 370 mgI/dLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in serum creatinine (SCr) at 48-72 hours post dose
Secondary outcomes (1)
Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJan 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kathleen S Bensel, CNMT, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289614
- Sponsor's protocol ID
- IOP 105
- Status last verified
- Jan 2008
- First submitted
- 8 Feb 2006
- Last updated
- 7 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Renal Impairment and Diabetes Undergoing Computed Tomography
- ClinicalTrials.gov ID
- NCT00289614
- Acronym / sponsor ID
- IOP 105
- Conditions
- Kidney Diseases
- Keywords
- contrast induced nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 10 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 main purpose of this study is to compare the incidence of contrast induced nephrotoxicity following the administration of Isovue (iopamidol) or Visipaque in diabetic patients with moderate to severe chronic renal impairment undergoing clinically indicated contrast enhanced multidetector computed tomography (MDCT). Serum creatinine will be measured before and up to 48-72 hours post dose.
Study design
- 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 (3 listed)
- Referred for contrast enhanced MDCT
- Documented predose eGFR of greater than or equal to 20 and less than 60 mL/min/1.73m2
- Diagnosed as having diabetes mellitus
Key exclusion criteria (4 listed)
- Unstable renal function
- Unstable diabetes
- Concurrent administration of nephrotoxic drugs
- Undergoing 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/dL | Drug | – |
Primary outcome
Increase in serum creatinine (SCr) at 48-72 hours post dose
1 secondary outcome
Decrease in estimated glomerular filtration rate (eGFR) at 48-72 hours post dose; occurrence of adverse events
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 7 Jan 2008.
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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.
Kathleen S Bensel, CNMT 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/dL in people with Kidney Diseases, 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 3 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 7 Jan 2008. 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 serum creatinine (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 7 Jan 2008.