E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Safety of the Contrast Enhanced Magnetic Resonance Imaging with ProHance in patients suffering from Chronic Kidney Disease (CKD) (stage 3 to 5 according to the classification of CKD by the National Kidney Foundation) stage 3 (cohort 1) stage 4-5 (cohort 2) |
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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 | 10029820 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038359 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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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 objective of this long-term, study is to prospectively compare the incidence of Nephrogenic Systemic Fibrosis (NSF) in two cohorts of patients treated with ProHance during a current diagnostic procedure with magnetic resonance imaging:
COHORT 1 - patients with moderate CKD (Chronic Kidney Disease) (stage 3, according to the classification of CKD by the National Kidney Foundation,32 i.e., with eGFR (estimated Glomerular Filtration Rate) comprised between 30 and 59 mL/min/1.73m2).
COHORT 2 - patients with severe CKD or kidney failure (stages 4 and 5, according to the classification of CKD by the National Kidney Foundation, i.e., with eGFR stably below 30 mL/min/1.73m2). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Enroll the patients who are going to receive or have just received PROHANCE injection during a Magnetic Resonance Imaging examination, provide written informed consent and are willing to comply with protocol requirements if they meet the following inclusion criteria: COHORT 1 • Has CKD with eGFR stably comprised between 30 and 59 mL/min/1.73m2, as calculated from a Serum Creatinine (SCr) value obtained from the local laboratory within 24 hours prior to the PROHANCE injection. COHORT 2 • Has CKD and/or undergoing dialysis with eGFR below 30 mL/min/1.73m2, as calculated from a SCr value obtained from the local laboratory within 24 hours prior to the PROHANCE injection.
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E.4 | Principal exclusion criteria |
Any patient must be excluded from the study if: • Has received a GBCA (Gadolinium Based Contrast Agent) within the past 12 months prior to inclusion in this study; • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; • Has ever been suspected of, or diagnosed with, NSF prior to the study-specific MRI; • Is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy and laboratory/other diagnostic evaluations should development of NSF be suspected.
and for the patients in cohort 1 • Has unstable kidney function;
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end points are to estimate and compare the incidence of NSF in the two cohorts at the 1-year follow-up time point and at the 2-year follow-up time point. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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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The end of study is defined as the last protocol-defined contact of any patient enrolled in the study. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |