Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006500

Trial Description

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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

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Trial Acronym

GRIP

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006500
  •   2015/04/14
  •   2008/12/18
  •   no
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Secondary IDs

  •   2008-004496-22 
  •   NCT00828737  (ClinicalTrials.gov)
  •   13273  (Bayer)
  •   2008-004496-22 
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Health Condition or Problem studied

  •   Fibrosis
  •   Renal Impairment
  •   N18 -  Chronic kidney disease
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Interventions/Observational Groups

  •   Drug: Gadobutrol (Gadovist, BAY86-4875)
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
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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: Within 2 years, after administration of Gadovist

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Secondary Outcome

- Confidence of the investigator to make a diagnosis based on the Gadovist enhanced magnetic resonance imaging (MRI) and to qualitatively assess the image quality; time frame: Immediately after Gadovist-enhanced MRI
- Adverse events collection; time frame: Immediately after Gadovist-enhanced MRI
- Characterize patients with moderate and severe renal impairment regarding specific cytokine expression in serum to evaluate potential co-factors under discussion in the pathogenesis of NSF; time frame: At baseline (prior to Gadovist-enhanced MRI)

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Countries of Recruitment

  •   Australia
  •   Austria
  •   Canada
  •   France
  •   Germany
  •   Italy
  •   Korea, Republic of
  •   Spain
  •   Switzerland
  •   Thailand
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Locations of Recruitment

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Recruitment

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  •   2008/12/31
  •   907
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   no maximum age
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Additional Inclusion Criteria

- 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

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Exclusion Criteria

- 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.

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer
    • Bayer Study Director 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.