E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 MDCTA scanning of the lower extremity arterial system |
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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 enhancement of key arteries 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 MDCTA scanning of the lower extremity arterial system with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™-320. |
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E.2.2 | Secondary objectives of the trial |
· To qualitatively compare the efficacy of enhancement in subjects, both overall and at a segmental/regional level, 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 MDCTA scanning of the lower extremity arterial system with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™-320.· 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 vs pre-dose value.· 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 MDCTA examination of the lower extremity arterial system. |
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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 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 24 hours prior to the start of study agent administration - by history (eg, 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 having received an investigational drug 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 the study objectives, 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 enhancement of key arteries during IV contrast-enhanced MDCTA scanning of the lower extremity arterial system with equi-iodine doses of one of two contrast agents, Iomeron®-400 or Visipaque™-320.Since all intravascular blood has approximately the same un-enhanced CT density, all values of intravascular enhancement will be measured, recorded and analyzed as absolute Hounsfield units as measured after contrast administration.The quantitative measurements of maximum CT density in HU, after contrast administration will be measured in six regions of interest: suprarenal abdominal aorta, infrarenal abdominal aorta, common iliac arteries, external iliac/common femoral arteries, superficial femoral arteries, popliteal arteries. Quantitative measurements in common iliac arteries, external iliac/common femoral arteries, superficial femoral arteries, popliteal arteries will be obtained both for right and left legs.The ANOVA model with repeated measures will be employed to evaluate the effect of contrast agent on the maximum enhancement of CT density (HU). ROIs clustered within subject will be treated as repeated effect.Separate analyses will be carried out for each of the three 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 |