Renal DiseasePhase 3NCT00980681
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
A Phase 3 study testing Dotarem and Time of Flight in people with Renal Disease, run by Guerbet at 1 site in United States.
Trial summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- What is being tested?
- Dotarem and Time of Flight
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 3
- 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
- Male or female, aged more than 18 years
- Strongly suspected of having renal arterial disease
- Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination
Who cannot join
- Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
- Contraindication to MRI
- Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Read the detailed description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
- Conditions
- Renal Disease
- Being tested
- Dotarem, Time of Flight
- Keywords
- Renal disease, Contrast agent, MRA
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DotaremDrug
Also called gadoteric acid, gadoterate meglumine
Each subject will receive one injection of Dotarem 0.2ml/kg
Time of FlightOther
Each subject will undergo a TOF MRA
| Study group | Role | What they receive |
|---|---|---|
| Dotarem | Experimental | Each subject will receive one injection of Dotarem 0.2ml/kg. Receives: Drug: Dotarem |
| Time Of Flight | Other | Each subject will undergo a TOF Magnetic Resonance Angiography Receives: Other: Time of Flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Non Assessable Renal Artery Segments
For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Measured: 1 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Lack of recruitment.
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 DiseaseStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pierre DESCHE, MD, Study director, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980681
- Sponsor's protocol ID
- DGD-44-047
- Status last verified
- Apr 2016
- First submitted
- 17 Sep 2009
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
- ClinicalTrials.gov ID
- NCT00980681
- Acronym / sponsor ID
- DGD-44-047
- Conditions
- Renal Disease
- Keywords
- Renal disease, Contrast agent, MRA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Posted 26 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Detailed description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dotarem | Experimental | Drug: DotaremEach subject will receive one injection of Dotarem 0.2ml/kg. |
| Time Of Flight | Other | Other: Time of FlightEach subject will undergo a TOF Magnetic Resonance Angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, aged more than 18 years
- Strongly suspected of having renal arterial disease
- Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination
Key exclusion criteria (3 listed)
- Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)
- Contraindication to MRI
- Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination
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 |
|---|---|---|
| DotaremAlso: gadoteric acid, gadoterate meglumineEach subject will receive one injection of Dotarem 0.2ml/kg | Drug | Dotarem |
| Time of FlightEach subject will undergo a TOF MRA | Other | Time Of Flight |
Primary outcome
Percent of Non Assessable Renal Artery Segments
Time frame: 1 to 7 days
For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Pierre DESCHE, MD study director
Guerbet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dotarem and Time of Flight in people with Renal Disease, run by Guerbet 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 3 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 26 May 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 May 2016). 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?
Percent of Non Assessable Renal Artery Segments (time frame: 1 to 7 days). 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 26 May 2016.