Trial Condition(s):

Fibrosis, Renal Impairment

Safety of Gadovist in Renally Impaired Patients (GRIP)

Bayer Identifier:

13273

ClinicalTrials.gov Identifier:

NCT00828737

EudraCT Number:

2008-004496-22

Study Completed

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.

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.

Trial Summary

Enrollment Goal
927
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Status
Completed
 
Locations

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Status
Completed
 
Locations

Klinikum Lüdenscheid- Untern.verb. Märkische Kliniken GmbH

Lüdenscheid, Germany, 58515

Status
Completed
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Completed
 
Locations

Nephrologisches Zentrum Niedersachsen

Hannoversch Münden, Germany, 34346

Status
Terminated
 
Locations

C.H.U. Timone

Marseille, France, 13385

Status
Terminated
 
Locations

Centre Hospitalier Universitaire - Le Kremlin Bicêtre

LE KREMLIN-BICETRE, France, 94275

Status
Terminated
 
Locations

CHRU Hôpital Cardiologique

Lille Cedex, France, 59037

Status
Terminated
 
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

A.O.U. Integrata Verona

Verona, Italy, 37134

Status
Completed
 
Locations

A.O. Spedali Civili

Brescia, Italy, 25123

Status
Completed
 
Locations

Università La Sapienza

Roma, Italy, 00161

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Umberto I - Lancisi - Salesi

Ancona, Italy, 60126

Status
Terminated
 
Locations

IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Completed
 
Locations

Klinikum der Eberhard-Karls-Universität Tübingen

Tübingen, Germany, 72076

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Klinikum Coburg gGmbH

Coburg, Germany, 96450

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04289

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Hôpital Europeen Georges Pompidou

Paris, France, 75908

Status
Terminated
 
Locations

Hopital Maison Blanche

REIMS, France, 51092

Status
Terminated
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

AULSS 09 Treviso - Veneto

Treviso, Italy, 31100

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56124

Status
Completed
 
Locations

A.O. Città della Salute e della Scienza di Torino

Torino, Italy, 10126

Status
Terminated
 
Locations

A.O.U. Meyer

Firenze, Italy, 50139

Status
Completed
 
Locations

Foothills Medical Centre

Calgary, Canada, T2N 2T9

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Completed
 
Locations

St. Joseph's Healthcare - Hamilton

Hamilton, Canada, L8N 4A6

Status
Completed
 
Locations

Toronto General Hospital-University Health Network

Toronto, Canada, M5G 2N2

Status
Completed
 
Locations

Monash Medical Centre

Clayton, Australia, 3168

Status
Terminated
 
Locations

Geelong Hospital

Geelong, Australia, 3220

Status
Completed
 
Locations

Westmead Hospital

Westmead NSW, Australia, 2145

Status
Terminated
 
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
 
Locations

A. ö. Landeskrankenhaus Leoben

Leoben, Austria, 8700

Status
Completed
 
Locations

Krankenanstalt der Stadt Wien - Rudolfstiftung

Wien, Austria, 1030

Status
Completed
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Completed
 
Locations

Bezirkskrankenhaus Reutte

Ehenbichl, Austria, 6600

Status
Completed
 
Locations

Chonbuk National University Hospital

Jeonju-Si, Jeonrabuk-Do, South Korea, 561-712

Status
Completed
 
Locations

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea, 137-701

Status
Completed
 
Locations

Cente Hospitalier Universitaire de Sherbrooke-Fleurimont

Fleurimont, Canada, J1H 5N4

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Terminated
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea, 120-752

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Ospedale regionale di Lugano

Lugano, Switzerland, 6900

Status
Terminated
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
 
Locations

Westmead Hospital

Westmead NSW, Australia, 2145

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Universitätsklinikum Regensburg

Regensburg, Germany, 93053

Status
Completed
 
Locations

Seoul Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Ruppiner Kliniken GmbH

Neuruppin, Germany, 16816

Status
Completed
 
Locations

Vivantes Klinikum Neukölln

Berlin, Germany, 12351

Status
Completed
 
Locations

Hanserad Radiologie Hamburg Praxisklinik Bergedorf

Hamburg, Germany, 21031

Status
Completed
 
Locations

Otto-von-Guericke-Universität Magdeburg

Magdeburg, Germany, 39120

Status
Completed
 
Locations

SRH Wald-Klinikum Gera gGmbH

Gera, Germany, 07548

Status
Completed
 
Locations

Hospital Clínico Universitario San Cecilio

Granada, Spain, 18012

Status
Completed
 
Locations

Prince of Songkla University

Songkhla , Thailand, 90110

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Terminated
 
Locations

Ramathibodhi Hospital

Bangkok, Thailand

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Terminated
 
Locations

St. Josefs-Hospital

Dortmund, Germany, 44263

Status
Completed
 
Locations

IRCCS INT Fondazione Pascale

Napoli, Italy, 80131

Status
Terminated
 
Locations

IRCCS Istituto Europeo Oncologia - IEO

Milano, Italy, 20141

Status
Terminated
 
Locations

Pusan National University Hospital

Busan, South Korea, 602-739

Status
Completed
 
Locations

Seoul National Univ. Bundang Hospital

SeongNam-si, South Korea, 463-707

Status
Completed
 
Locations

IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 

Trial Design