check_circleStudy Completed

Fibrosis, Renal Impairment

Bayer Identifier:

13273

ClinicalTrials.gov Identifier:

NCT00828737

EudraCT Number:

2008-004496-22

EU CT Number:

Not Available
Safety of Gadovist in Renally Impaired Patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

2 - N/A
  • - 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
  • - 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 summary

Enrollment Goal
927
Trial Dates
December 2008 - January 2015
Phase
Phase 4
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum Osnabrück GmbHOsnabrück, 49076, Germany
Completed
Universitätsklinikum ErlangenErlangen, 91054, Germany
Completed
Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbHLüdenscheid, 58515, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Terminated
Nephrologisches Zentrum NiedersachsenHannoversch Münden, 34346, Germany
Terminated
C.H.U. TimoneMarseille, 13385, France
Terminated
Centre Hospitalier Universitaire - Le Kremlin BicêtreLE KREMLIN-BICETRE, 94275, France
Terminated
CHRU Hôpital CardiologiqueLille Cedex, 59037, France
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
A.O.U. Integrata VeronaVerona, 37134, Italy
Completed
A.O. Spedali CiviliBrescia, 25123, Italy
Completed
Università La SapienzaRoma, 00161, Italy
Terminated
A.O.U. Ospedali Riuniti Umberto I - Lancisi - SalesiAncona, 60126, Italy
Completed
IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca CancroGenova, 16132, Italy
Completed
Klinikum Mannheim gGmbHMannheim, 68167, Germany
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Klinikum Coburg gGmbHCoburg, 96450, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04289, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60596, Germany
Terminated
Hôpital Europeen Georges PompidouParis, 75908, France
Terminated
Hopital Maison BlancheREIMS, 51092, France
Completed
Università Cattolica del Sacro CuoreRoma, 00168, Italy
Completed
AULSS 09 Treviso - VenetoTreviso, 31100, Italy
Completed
A.O.U. PisanaPisa, 56124, Italy
Terminated
A.O. Città della Salute e della Scienza di TorinoTorino, 10126, Italy
Completed
A.O.U. MeyerFirenze, 50139, Italy
Completed
Foothills Medical CentreCalgary, T2N 2T9, Canada
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Completed
Corporació Sanitària Parc TaulíSabadell, 08208, Spain
Completed
St. Joseph's Healthcare - HamiltonHamilton, L8N 4A6, Canada
Completed
Toronto General Hospital-University Health NetworkToronto, M5G 2N2, Canada
Terminated
Monash Medical CentreClayton, 3168, Australia
Completed
Geelong HospitalGeelong, 3220, Australia
Terminated
Westmead HospitalWestmead NSW, 2145, Australia
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
A. ö. Landeskrankenhaus LeobenLeoben, 8700, Austria
Completed
Krankenanstalt der Stadt Wien - RudolfstiftungWien, 1030, Austria
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Bezirkskrankenhaus ReutteEhenbichl, 6600, Austria
Completed
Chonbuk National University HospitalJeonju-Si, Jeonrabuk-Do, 561-712, Korea, Republic Of
Completed
The Catholic University of Korea Seoul St. Mary's HospitalSeoul, 137-701, Korea, Republic Of
Completed
Cente Hospitalier Universitaire de Sherbrooke-FleurimontFleurimont, J1H 5N4, Canada
Completed
Sunnybrook Health Sciences CentreToronto, M4N 3M5, Canada
Terminated
Royal Adelaide HospitalAdelaide, 5000, Australia
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Severance Hospital, Yonsei University College of MedicineSeoul, 120-752, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Terminated
Ospedale regionale di LuganoLugano, 6900, Switzerland
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Completed
Westmead HospitalWestmead NSW, 2145, Australia
Completed
LMU Klinikum der Universität München - GroßhadernMünchen, 81377, Germany
Completed
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Completed
Seoul Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Ruppiner Kliniken GmbHNeuruppin, 16816, Germany
Completed
Vivantes Klinikum NeuköllnBerlin, 12351, Germany
Completed
Hanserad Radiologie Hamburg Praxisklinik BergedorfHamburg, 21031, Germany
Completed
Otto-von-Guericke-Universität MagdeburgMagdeburg, 39120, Germany
Completed
SRH Wald-Klinikum Gera gGmbHGera, 07548, Germany
Completed
Hospital Clínico Universitario San CecilioGranada, 18012, Spain
Completed
Prince of Songkla UniversitySongkhla, 90110, Thailand
Terminated
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
Ramathibodhi HospitalBangkok, Thailand
Terminated
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
St. Josefs-HospitalDortmund, 44263, Germany
Terminated
IRCCS INT Fondazione PascaleNapoli, 80131, Italy
Terminated
IRCCS Istituto Europeo Oncologia - IEOMilano, 20141, Italy
Completed
Pusan National University HospitalBusan, 602-739, Korea, Republic Of
Completed
Seoul National Univ. Bundang HospitalSeongNam-si, 463-707, Korea, Republic Of
Completed
IRCCS Istituto Clinico HumanitasRozzano, 20089, Italy

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
    date_rangeTime Frame:
    From the time of MRI until the end of follow-up period (24 months)
    enhanced_encryption
    Safety Issue:
    yes

Secondary Outcome

  • 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
    date_rangeTime Frame:
    From the time of MRI until the end of follow-up period (24 months)
    enhanced_encryption
    Safety Issue:
    No
  • Number of Participants With Different Criteria of Diagnostic Confidence of the Investigator Based on
    date_rangeTime Frame:
    Immediately after Gadovist-enhanced MRI
    enhanced_encryption
    Safety Issue:
    No
  • Number of Participants With Image Quality Sufficient for Diagnosis
    date_rangeTime Frame:
    Immediately after Gadovist-enhanced MRI
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Creactive Protein (CRP) in Participants With Moderate and Severe Renal Impairment
    date_rangeTime Frame:
    Within 48 hours prior to the Gadovist administration
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Macrophage Inflammatory Proteins (MIP) and Monocyte Chemotactic Proteins (MCP) in Participants With Moderate and Severe Renal Impairment
    date_rangeTime Frame:
    Within 48 hours prior to the Gadovist administration
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of Osteopontin and Tissue Inhibitor of Metallo Proteinase 1 (TIMP1) in Participants With Moderate and Severe Renal Impairment
    date_rangeTime Frame:
    Within 48 hours prior to the Gadovist administration
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    From the time of MRI until the end of follow-up period (24 months)
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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