E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate to severe renal impairment. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038474 |
E.1.2 | Term | Renal insufficiency |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with moderate to severe renal impairment, who develop NSF, based on diagnostically specific clinical and histopathological information. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial is defined as last patient last visit which is scheduled for end of August 2010. There is a 24 months follow-up period planned for each patient which ends with a face-to face visit with the investigator (last vist). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |