EUCTR2008-005867-33-DE
Active, not recruiting
Not Applicable
Prospective non-randomized (pharmacoepidemiologic) cohort study (open-label, multicenter) to assess the magnitude of potential risk with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of nephrogenic systemic fibrosis (NSF) based on diagnostically specific clinical and histopathologic information. - Primovist/Eovist in Renally Impaired patients (the PERI study)
ConditionsPatients with moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe renal impairment (eGFR < 30 mL/min/1.73 m2) scheduled to undergo contrast-enhanced MRI with Primovist/Eovist.MedDRA version: 15.1Level: LLTClassification code 10038469Term: Renal impairment NOSSystem Organ Class: 100000004857Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients with moderate (eGFR 30 – 59 mL/min/1.73 m2) to severe renal impairment (eGFR < 30 mL/min/1.73 m2) scheduled to undergo contrast-enhanced MRI with Primovist/Eovist.
- Sponsor
- Bayer HealthCare AG
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must be scheduled for CE\-MRI OF THE LIVER with Primovist/Eovist based on careful risk/benefit evaluation at the recommended dose in one of the approved indications
- •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 will initially be qualified using the simplified MDRD formula, based on a determination of serum creatinine within 6 weeks prior to the administration of Primovist/Eovist. Final patient stratification will be based on the complete MDRD formula (13\) based on age, gender, ethnicity; and on serum creatinine, serum urea nitrogen, and serum albumin concentration as measured within 24h prior to Primovist/Eovist administration.
- •Patient must sign study\-specific informed consent.
- •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 1000
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1000
Exclusion Criteria
- •GBCA\-enhanced MRI (or administration of a GBCA for any other CE imaging procedure) other than Primovist/Eovist within 12 months prior to administration of Primovist/Eovist
- •\-Rationale for selected time window: to minimize level of confounding from prior administration of GBCA for the estimation of risk of NSF for Primovist/Eovist while at the same time avoiding the elimination of too many potential participants from the study.
- •\-Exposure to GBCA within 12 months prior to administration of Primovist/Eovist will be determined at the time of the initial evaluation via history (elicited from patient) and review of patient’s medical records, if available at that time. Subsequently, a more thorough analysis of the patient’s medical records will be carried out to ascertain the accuracy of the GBCA exposure information obtained at the time of the ÌNITIAL EVALUATION
Outcomes
Primary Outcomes
Not specified
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