Coronary Artery DiseasePhase 4NCT00209430
Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Coronary Angiography
A Phase 4 study testing Iodixanol 320 mgI/mL in people with Coronary Artery Disease and Renal Impairment, run by GE Healthcare at 1 site in Sweden.
Trial summary
The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Renal Impairment
- What is being tested?
- Iodixanol 320 mgI/mL
- How many people
- 408 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2005to not given
- 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
- Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.
Who cannot join
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.
The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Read the detailed description
GEHC has decided not to provide this detail
- Conditions
- Coronary Artery Disease, Renal Impairment
- Being tested
- Iodixanol 320 mgI/mL
- Keywords
- Iodixanol, Iopamidol, coronary angiography, Contrast media-induced nephropathy
- Medical subject headings
- Coronary Artery Disease, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodixanol 320 mgI/mLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak increase in SCr
Incidence of contrast media-induced nephropathy from baseline up to day 3.
Secondary outcomes (3)
SCr concentrations up to days 3 and 7
image quality
occurrence of adverse events and their severity and relationship with the contrast media.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 408 participants
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Caroline Widlund, BSc RN, Study director, GE HealthcareJohnny Gibbs, Jr., B.S., CCRA, Study director, 609-514-6809
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209430
- Sponsor's protocol ID
- DXV405
- Status last verified
- Oct 2007
- First submitted
- 13 Sep 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Publications
Laskey W, Aspelin P, Davidson C, Rudnick M, Aubry P, Kumar S, Gietzen F, Wiemer M; DXV405 Study Group. Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. Am Heart J. 2009 Nov;158(5):822-828.e3. doi: 10.1016/j.ahj.2009.08.016.
PubMed 19853704
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title.
- ClinicalTrials.gov ID
- NCT00209430
- Acronym / sponsor ID
- DXV405
- Conditions
- Coronary Artery Disease, Renal Impairment
- Keywords
- Iodixanol, Iopamidol, coronary angiography, Contrast media-induced nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- First posted
- 21 Sep 2005 (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 evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
Detailed description
GEHC has decided not to provide this detail
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 (1 listed)
- Subjects with a combination of diabetes mellitus (type I or II) and renal impairment, defined as serum creatinine (SCr ) ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤ 50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.
Key exclusion criteria (1 listed)
- Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplant will not be included.
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 |
|---|---|---|
| Iodixanol 320 mgI/mL | Drug | – |
Primary outcome
Peak increase in SCr
Incidence of contrast media-induced nephropathy from baseline up to day 3.
3 secondary outcomes
SCr concentrations up to days 3 and 7
image quality
occurrence of adverse events and their severity and relationship with the contrast media.
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 31 Oct 2007.
- Derived from this study: PubMed 19853704Laskey W, Aspelin P, Davidson C, Rudnick M, Aubry P, Kumar S, Gietzen F, Wiemer M; DXV405 Study Group. Nephrotoxicity of iodixanol versus iopamidol in patients with chronic kidney disease and diabetes mellitus undergoing coronary angiographic procedures. Am Heart J. 2009 Nov;158(5):822-828.e3. doi: 10.1016/j.ahj.2009.08.016.
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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.
Caroline Widlund, BSc RN study director
GE Healthcare
Johnny Gibbs, Jr., B.S., CCRA study director
609-514-6809
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 Iodixanol 320 mgI/mL in people with Coronary Artery Disease and Renal Impairment, run by GE Healthcare at 1 site in Sweden.
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 1 inclusion and 1 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 31 Oct 2007. 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 Sweden. 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?
Peak increase in SCr. The study lists 2 primary outcomes in all. 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 NCT00209430, 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 31 Oct 2007.