Patients with moderate to severe renal impairment. MedDRA version: 14.1 Level: LLT Classification code 10038469 Term: Renal impairment NOS System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Gadovist® 1.0 mmol/ml, solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: gadobutrol
CAS Number: 138071-82-6
Current Sponsor code: ZK 135 079
Concentra
Sponsors
Bayer Health Care AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patient must be scheduled for CE-MRI with Gadovist based on careful risk-benefit evaluation at the recommended dose(s) in one of the approved indications. • Patient must fulfill criteria for moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe (eGFR =65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
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 existing NSF • Age less than 18 years • Patients who are clinically unstable and whose clinical course is unpredictable • Age outside the indicated age range mentioned in national labelling. (In countries where Gadovist is indicated for use in children, children are also eligible for inclusion according to national labelling).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the magnitude of potential risk with the administration of Gadovist in patients with moderate to severe renal impairment for the development of NSF, based on diagnostically specific clinical and histopathological information.;Secondary Objective: Secondary objectives are • to assess the magnitude of the potential risk with the administration of Gadovist in patients with moderate and severe renal impairment for the development of cutaneous symptoms consistent with NSF, based on specific clinical information for patients in whom biopsy is not available • to 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 (at baseline) • to evaluate the confidence of the investigator to make a diagnosis based on the Gadovist enhanced MRI and to qualitatively assess the image quality • to evaluate the number and characteristics of adverse events reported in association with the administration of Gadovist. ;Primary end point(s): Number of patients with moderate to severe renal impairment, who develop NSF, based on diagnostically specific clinical and histopathological information.;Timepoint(s) of evaluation of this end point: LPLV, 31 December 2014 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of patients with moderate to severe renal impairment in whom no biopsy was obtained who develop NSF based on diagnostically specific clinical information;Timepoint(s) of evaluation of this end point: After 2 years of follow-up period | — |
Countries
Australia, Austria, Canada, France, Germany, Italy, Korea, Republic of, Spain, Switzerland
Contacts
Public ContactBayer Clinical Trials Contact
Bayer HealthCare AG
Outcome results
None listed