Saftey of Primovist/Eovist in Renally Impaired patients

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005867-33-DE

Enrollment

1000

Registered

2009-01-20

Start date

2009-03-10

Completion date

Unknown

Last updated

2014-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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. MedDRA version: 15.1 Level: LLT Classification code 10038469 Term: Renal impairment NOS System Organ Class: 100000004857

Interventions

Trade Name: Primovist 0.25 mmol/ml, solution for injection Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Gadoxetate disodium CAS Number: 135326-22-6 Current Sp

Eligibility

Sex/Gender

All

Inclusion 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 =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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the magnitude of potential risk of developing NSF with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of NSF, based on diagnostically specific clinical and histopathological information.;Secondary Objective: •to assess the magnitude of the potential risk of developing cutaneous symptoms consistent with NSF with the administration of Primovist/Eovist in patients with moderate to 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 evaluate the confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI •to determine imaging efficacy by qualitatively evaluating the parameters “lesion detection”, “lesion delineation” and “lesion characterization”. •to evaluate the number and characteristics of adverse events reported in association with the administration of Primovist/Eovist. ;Primary end point(s): The primary end point of the study is the number of patients with moderate to severe renal impairment who develop NSF, based on diagnostically specific clinical and histopathological information, following the administration of Primovist/Eovist injection within the 2-year follow-up period.;Timepoint(s) of evaluation of this end point: LPLV - 31 december 2014	—

Measure

Time frame

Main Objective: The primary objective is to assess the magnitude of potential risk of developing NSF with the administration of Primovist/Eovist in patients with moderate to severe renal impairment for the development of NSF, based on diagnostically specific clinical and histopathological information.;Secondary Objective: •to assess the magnitude of the potential risk of developing cutaneous symptoms consistent with NSF with the administration of Primovist/Eovist in patients with moderate to 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 evaluate the confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI •to determine imaging efficacy by qualitatively evaluating the parameters “lesion detection”, “lesion delineation” and “lesion characterization”. •to evaluate the number and characteristics of adverse events reported in association with the administration of Primovist/Eovist. ;Primary end point(s): The primary end point of the study is the number of patients with moderate to severe renal impairment who develop NSF, based on diagnostically specific clinical and histopathological information, following the administration of Primovist/Eovist injection within the 2-year follow-up period.;Timepoint(s) of evaluation of this end point: LPLV - 31 december 2014

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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. The clinical findings related to NSF will be summarized by clinical score. • Confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI. • Number and characteristics of adverse events reported in association with the administration of Primovist/Eovist. • Number of patients with “Excellent / Good / Adequate / Insufficient” scores for “lesion detection”, “lesion delineation” and “lesion characterization. ;Timepoint(s) of evaluation of this end point: After 2 years follow-up	—

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. The clinical findings related to NSF will be summarized by clinical score. • Confidence of the investigator to make a diagnosis based on the Primovist/Eovist enhanced MRI. • Number and characteristics of adverse events reported in association with the administration of Primovist/Eovist. • Number of patients with “Excellent / Good / Adequate / Insufficient” scores for “lesion detection”, “lesion delineation” and “lesion characterization. ;Timepoint(s) of evaluation of this end point: After 2 years follow-up

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Countries

Australia, Austria, Germany, Italy, Korea, Republic of, Spain, Thailand, United Kingdom, United States

Contacts

Public ContactCTP Team/ Ref:"EU CTR" /

Bayer HealthCare AG

clinical-trials-contact@bayer.comNANANANA

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026