FibrosisPhase 4GRIPNCT00828737
Safety of Gadovist in Renally Impaired Patients
A Phase 4 study testing Gadobutrol (Gadovist, BAY86-4875) in people with Fibrosis and Renal Impairment, run by Bayer at 70 sites in 10 countries.
Trial summary
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Fibrosis, Renal Impairment
- What is being tested?
- Gadobutrol (Gadovist, BAY86-4875)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 927 participants
- Where
- 70 sitesin 10 countries
- Study dates
- Dec 2008to Jan 2015
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR < 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI
Who cannot join
- GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist
- History of NSF (Nephrogenic Fibrosing Dermopathy)
- Age outside the indicated age range mentioned in national labelling.
Trial locations and contacts
70 sites in 10 countries.
70 sites in 10 countries
Germany20 sites
Study site
Berlin, State of Berlin, 12200
Study site
Berlin, State of Berlin, 12351
Study site
Coburg, Bavaria, 96450
Study site
Dortmund, North Rhine-Westphalia, 44263
Study site
Dresden, Saxony, 01307
Study site
Erlangen, Bavaria, 91054
Study site
Essen, North Rhine-Westphalia, 45122
Study site
Frankfurt am Main, Hesse, 60596
Study site
Gera, Thuringia, 07548
Study site
Hamburg, Free and Hanseatic City of Hamburg, 21031
Study site
Hannoversch Münden, Lower Saxony, 34346
Study site
Leipzig, Saxony, 04289
Study site
Lüdenscheid, North Rhine-Westphalia, 58515
Study site
Magdeburg, Saxony-Anhalt, 39120
Study site
Mannheim, Baden-Wurttemberg, 68167
Study site
München, Bavaria, 81377
Study site
Neuruppin, Brandenburg, 16816
Study site
Osnabrück, Lower Saxony, 49076
Study site
Regensburg, Bavaria, 93053
Study site
Tübingen, Baden-Wurttemberg, 72076
Italy14 sites
Study site
Ancona, 60126
Study site
Brescia, 25123
Study site
Florence, 50139
Study site
Genova, 16132
Study site
Milan, 20132
Study site
Milan, 20141
Study site
Naples, 80131
Study site
Pisa, 56124
Study site
Roma, 00161
Study site
Roma, 00168
Study site
Rozzano, Milano, 20089
Study site
Torino, 10126
Study site
Treviso, 31100
Study site
Verona, 37134
South Korea8 sites
Study site
Busan, 602-739
Study site
Jeonju-Si, Jeonrabuk-Do, 561-712
Study site
Seongnam-si, Gyeonggido, 463-707
Study site
Seoul, Seoul Teugbyeolsi, 110-744
Study site
Seoul, 120-752
Study site
Seoul, 135-710
Study site
Seoul, 137-701
Study site
Seoul, 138-736
Austria6 sites
Study site
Ehenbichl, 6600
Study site
Graz, 8036
Study site
Innsbruck, Tyrol, 6020
Study site
Leoben, 8700
Study site
Vienna, 1030
Study site
Vienna, 1090
Canada5 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Fleurimont, Quebec, J1H 5N4
Study site
Hamilton, Ontario, L8N 4A6
Study site
Toronto, Ontario, M4N 3M5
Study site
Toronto, Ontario, M5G 2N2
France5 sites
Study site
Le Kremlin-Bicêtre, 94275
Study site
Lille, 59037
Study site
Marseille, 13385
Study site
Paris, 75908
Study site
Reims, 51092
Australia4 sites
Study site
Adelaide, South Australia, 5000
Study site
Clayton, Victoria, 3168
Study site
Geelong, Victoria, 3220
Study site
Westmead NSW, 2145
Spain3 sites
Study site
Barcelona, Barcelona, 08036
Study site
Granada, Granada, 18012
Study site
Sabadell, Barcelona, 08208
Thailand3 sites
Study site
Bangkok, 10700
Study site
Bangkok
Study site
Songkhla, 90110
Switzerland2 sites
Study site
Basel, Canton of Basel-City, 4031
Study site
Lugano, Canton Ticino, 6900
About this study
Official title: Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Gadovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.
The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
- Conditions
- Fibrosis, Renal Impairment
- Being tested
- Gadobutrol (Gadovist, BAY86-4875)
- Medical subject headings
- Fibrosis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadovist, BAY86-4875)Drug
Gadovist in approved indications at approved dosages
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadobutrol (Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information
Measured: From the time of MRI until the end of follow-up period (24 months)
Secondary outcomes (7)
Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy was Obtained who Develop Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical Information
Measured: From the time of MRI until the end of follow-up period (24 months)
Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on
Measured: Immediately after Gadovist-enhanced MRI
Number of Participants With Image Quality Sufficient for Diagnosis
Measured: Immediately after Gadovist-enhanced MRI
Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment
Measured: Within 48 hours prior to the Gadovist administration
Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment
Measured: Within 48 hours prior to the Gadovist administration
Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment
Measured: Within 48 hours prior to the Gadovist administration
Number of Participants With Treatmentemergent Adverse Events (TEAEs), Treatmentemergent Serious Adverse Event (TESAE), Drugrelated Treatmentemergent Adverse Events (TEAEs) and Drugrelated Treatmentemergent Serious Adverse Events (TESAEs)
Measured: From the time of MRI until the end of follow-up period (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosisStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828737
- Sponsor's protocol ID
- 13273
- Other IDs
- 2008-004496-22, 2008
- Acronym
- GRIP
- Status last verified
- Feb 2016
- First submitted
- 18 Dec 2008
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Gadovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information
- ClinicalTrials.gov ID
- NCT00828737
- Acronym / sponsor ID
- GRIP / 13273
- Conditions
- Fibrosis, Renal Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Jan 2009 (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.
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.
The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gadobutrol (Gadovist, BAY86-4875) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with moderate (eGFR 30 - 59 ml/min/173m2) or severe (eGFR < 30 ml/min/1.73m2) renal impairment, scheduled to undergo Gadovist-enhanced MRI
Key exclusion criteria (3 listed)
- GBCA-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Gadovist within 12 months prior to administration of Gadovist
- History of NSF (Nephrogenic Fibrosing Dermopathy)
- Age outside the indicated age range mentioned in national labelling.
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 |
|---|---|---|
| Gadobutrol (Gadovist, BAY86-4875)Gadovist in approved indications at approved dosages | Drug | Arm 1 |
Primary outcome
Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information
Time frame: From the time of MRI until the end of follow-up period (24 months)
7 secondary outcomes
Number of Participants With Moderate to Severe Renal Impairment in Whom no Biopsy was Obtained who Develop Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical Information
Time frame: From the time of MRI until the end of follow-up period (24 months)
Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on
Time frame: Immediately after Gadovist-enhanced MRI
Number of Participants With Image Quality Sufficient for Diagnosis
Time frame: Immediately after Gadovist-enhanced MRI
Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment
Time frame: Within 48 hours prior to the Gadovist administration
Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment
Time frame: Within 48 hours prior to the Gadovist administration
Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment
Time frame: Within 48 hours prior to the Gadovist administration
Number of Participants With Treatmentemergent Adverse Events (TEAEs), Treatmentemergent Serious Adverse Event (TESAE), Drugrelated Treatmentemergent Adverse Events (TEAEs) and Drugrelated Treatmentemergent Serious Adverse Events (TESAEs)
Time frame: From the time of MRI until the end of follow-up period (24 months)
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 18 Feb 2016.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
70 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadobutrol (Gadovist, BAY86-4875) in people with Fibrosis and Renal Impairment, run by Bayer at 70 sites in 10 countries.
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 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: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Germany, Italy, South Korea, Austria, Canada and 5 more countries. 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?
Number of patients with moderate to severe renal impairment, who develop Nephrogenic Systemic Fibrosis (NSF), based on diagnostically specific clinical and histopathological information (time frame: From the time of MRI until the end of follow-up period (24 months)). 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 18 Feb 2016.