Safety of Gadovist in Renally Impaired Patients (GRIP)

February 16, 2016 updated by: Bayer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

927

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Westmead NSW, Australia, 2145
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Geelong, Victoria, Australia, 3220
  • Austria
      • Ehenbichl, Austria, 6600
      • Graz, Austria, 8036
      • Leoben, Austria, 8700
      • Wien, Austria, 1030
      • Wien, Austria, 1090
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 2N2
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
  • France
      • Le Kremlin-bicetre, France, 94275
      • Lille Cedex, France, 59037
      • Marseille, France, 13385
      • Paris, France, 75908
      • Reims, France, 51092
  • Germany
      • Berlin, Germany, 12200
      • Berlin, Germany, 12351
      • Hamburg, Germany, 21031
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68167
      • Tübingen, Baden-Württemberg, Germany, 72076
    • Bayern
      • Coburg, Bayern, Germany, 96450
      • Erlangen, Bayern, Germany, 91054
      • München, Bayern, Germany, 81377
      • Regensburg, Bayern, Germany, 93053
    • Brandenburg
      • Neuruppin, Brandenburg, Germany, 16816
    • Hessen
      • Frankfurt, Hessen, Germany, 60596
    • Niedersachsen
      • Hannoversch Münden, Niedersachsen, Germany, 34346
      • Osnabrück, Niedersachsen, Germany, 49076
    • Nordrhein-Westfalen
      • Dortmund, Nordrhein-Westfalen, Germany, 44263
      • Essen, Nordrhein-Westfalen, Germany, 45122
      • Lüdenscheid, Nordrhein-Westfalen, Germany, 58515
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04289
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
    • Thüringen
      • Gera, Thüringen, Germany, 07548
  • Italy
      • Ancona, Italy, 60126
      • Brescia, Italy, 25123
      • Firenze, Italy, 50139
      • Genova, Italy, 16132
      • Milano, Italy, 20132
      • Milano, Italy, 20141
      • Napoli, Italy, 80131
      • Pisa, Italy, 56124
      • Roma, Italy, 00161
      • Roma, Italy, 00168
      • Torino, Italy, 10126
      • Treviso, Italy, 31100
      • Verona, Italy, 37134
    • Milano
      • Rozzano, Milano, Italy, 20089
  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
      • Jeonju-Si, Jeonrabuk-Do, Korea, Republic of, 561-712
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
    • Gyeonggido
      • SeongNam-si, Gyeonggido, Korea, Republic of, 463-707
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744
  • Spain
      • Barcelona, Spain, 08036
      • Granada, Spain, 18012
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
  • Switzerland
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
  • Thailand
      • Bangkok, Thailand
      • Bangkok, Thailand, 10700
      • Songkhla, Thailand, 90110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Gadobutrol (Gadovist, BAY86-4875)
Gadovist in approved indications at approved dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From the time of MRI until the end of follow-up period (24 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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
Immediately after Gadovist-enhanced MRI
Number of Participants With Image Quality Sufficient for Diagnosis
Time Frame: Immediately after Gadovist-enhanced MRI
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
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
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
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)
From the time of MRI until the end of follow-up period (24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

January 1, 2015

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

January 23, 2009

First Posted (ESTIMATE)

January 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13273
  • 2008-004496-22 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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