E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
subjects with mild to moderate renal impairment scheduled to undergo clinically-indicated IV contrast –enhanced MDCT scanning of the liver |
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MedDRA Classification |
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 |
To quantitatively compare the efficacy of arterial phase and portal venous phase enhancement of key vessels and normal liver parenchyma in subjects with mild to moderate renal impairment (SCr =1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min) who undergo clinically-indicated IV contrast-enhanced MDCT scanning of the liver with equi-iodine doses of one of two contrast agents: Visipaque™320 or Iomeron®-400. |
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E.2.2 | Secondary objectives of the trial |
To qualitatively compare the efficacy of arterial phase and portal venous phase scans in subjects with mild to moderate renal impairment, who undergo clinically-indicated IV contrast-enhanced MDCT scanning of the liver with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™ 320. To quantitatively compare between the two study agents the maximum differentiation of enhancement (expressed as a ‘delta’, which may be positive or negative in value) of focal liver lesions (if present) vs. adjacent normal liver parenchyma. To compare between the two study agents the incidence of contrast-induced nephropathy (CIN), defined as a >0.5 mg/dL post-CT scan increase in serum creatinine at 48-72 hours post-dose. To compare between the two study agents the incidence of delayed (2 hours to 7 days post-administration) hypersensitivity-type cutaneous/subcutaneous adverse reactions.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Provide written Informed Consent and are willing to comply with protocol requirements 18 years of age or older, Have a stable* baseline serum creatinine level of SCr =1.5-2.5 mg/dL and/or calculated CrCl = 10-60 mL/min. *2 stable values: one within 6 months and one within 2 weeks before the examination, Referred for a clinically-indicated contrast-enhanced MDCT examination of the liver
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E.4 | Principal exclusion criteria |
Determined, by their physicians, that prophylactic medication is medically required for them to receive intravascular administration of an iodinated contrast agent, A history of hypersensitivity to iodine-containing compounds, Severe congestive heart failure (class III-IV NYHA), Suspicion of hyperthyroidism or thyroid malignancies, Undergone or is scheduled to undergo any other radiological procedure utilizing x-ray contrast media from 72 hours before to 7 days after the administration of the study agent, Uncontrolled diabetes, Dialysis, Unstable renal function / serum creatinine levels/acute renal failure, Is a pregnant or lactating female. Exclude the possibility of pregnancy by testing on site at the institution (serum or urine βHCG) within 72 hours prior to the start of study agent administration - by history (tubal ligation or hysterectomy) - post menopausal with a minimum 1 year without menses (time of pregnancy test in relation to study agent administration must be recorded); Previously entered in this study or received an investigational compound within 30 days prior to admission to this study, Any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data or achieving post dose follow-up examinations i.e.: • drug dependence, • psychiatric disorders, dementia, or other reasons for expected poor compliance with investigator’s instructions.
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E.5 End points |
E.5.1 | Primary end point(s) |
To quantitatively compare the efficacy of arterial phase and portal venous phase enhancement of key vessels and normal liver parenchyma during IV contrast-enhanced MDCT scanning of the liver with equi-iodine doses of either ISOVUE or VISIPAQUE. The quantitative measurements of maximum CT density in HU, after contrast administration will be analyzed by means of the Student’s t test for unpaired data. A separate analysis will be carried out for each of the three off-site blinded readers.
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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Last visit of the last subject undergoing the trial |
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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 | 1 |
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 | 1 |