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Clinical Trials/EUCTR2008-004496-22-FR
EUCTR2008-004496-22-FR
Active, not recruiting
Phase 1

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 - Safety of Gadovist® in Renally Impaired Patients (the GRIP study)

Bayer Health Care AG (study performed by Bayer Schering Pharma AG)0 sites926 target enrollmentMarch 19, 2009
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ConditionsPatients with moderate to severe renal impairment.MedDRA version: 9.1Level: LLTClassification code 10038474Term: Renal insufficiency
DrugsGadovist 1,0 mmol/ml, solution injectable en seringue préremplie.

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with moderate to severe renal impairment.
Sponsor
Bayer Health Care AG (study performed by Bayer Schering Pharma AG)
Enrollment
926
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 19, 2009
End Date
January 27, 2015
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Bayer Health Care AG (study performed by Bayer Schering Pharma AG)

Eligibility Criteria

Inclusion Criteria

  • •Patient must be scheduled for CE\-MRI with Gadovist at the recommended dose(s) in one of the approved indications (for details see Appendix 1 Patient Information Leaflet of Gadovist”)
  • •Patient must fulfill criteria for moderate (eGFR 30 – 59 mL/min/1\.73 m2\) to severe (eGFR \< 30 mL/min/1\.73 m2\) renal impairment.
  • •Patients on chronic dialysis (both hemodialysis or peritoneal dialysis) will be automatically assigned to the severe” group and will not specifically require eGFR determination
  • •Patient must sign study\-specific informed consent.
  • •Patients are to be imaged according to the MR imaging protocols in the participating institutions, which include that physicians are to comply with the general precaution measures of MR imaging.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •GBCA\-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) within 12 months prior to administration of Gadovist
  • •History of existing NSF
  • •Age less than 18 years
  • •Patients who are clinically unstable and whose clinical course is unpredictable

Outcomes

Primary Outcomes

Not specified

Similar Trials

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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 - Safety of Gadovist® in Renally Impaired Patients (the GRIP study)Patients with moderate to severe renal impairment.MedDRA version: 9.1Level: LLTClassification code 10038474Term: Renal insufficiency
EUCTR2008-004496-22-ATBayer Health Care AG (study performed by Bayer Schering Pharma AG)1,000
Active, not recruiting
Not Applicable
Safety of Gadovist® in Renally Impaired PatientsPatients with moderate to severe renal impairment.MedDRA version: 14.1Level: LLTClassification code 10038469Term: Renal impairment NOSSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
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