E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glomerular Filtration Rate (GFR). We are comparing a new method of measuring GFR (an Iohexol infusion) with a standard method, recommended by NICE (an Iohexol bolus), in healthy volunteers and patients with Chronic Kidney Disease. |
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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 |
The Research question is: "Can kidney function (termed "Glomerular Filtration rate" or "GFR") be measured accurately by an Iohexol infusion?"
We will compare a new method (Method B , an infusion of Iohexol) with a standard method (Method A, Iohexol injection) of measuring GFR. We will assess this in people with normal kidney function, and in stable voluteers with varying stages of reduced kidney function (i.e. "chronic kidney disease") |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy volunteers – aged between 18 years and 75 years. 2. Patients with established stable CKD from stages 1-4. 3. All volunteers must have a Body Mass Index of 20-30Kg/m2. 4. Female volunteers and patients must provide evidence that they are not pregnant or lactating, or that they are post-menopausal. A urine pregnancy test (β-hCG) will be performed on visit 1 if no other credible evidence, such as sterilisation or post-menopausal status is given. Confirmation of the use of adequate birth control will be required in pre-menopausal women that give no evidence of an inability to become pregnant.Male volunteers will be requested to use contraception for the duration of their involvement in the trial, and for one week afterwards.
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E.4 | Principal exclusion criteria |
1. People with a previous allergic reaction to radio-contrast media,Iodine or shellfish. 2. People with known thyroid disease, myaesthenia gravis, cardiac arrhythmias, pulmonary hypertension, epilepsy, structural cerebral disease, phaeochromocytoma, advanced heart failure, sickle cell disease, multiple myeloma or homocystinuria. 3. Those in whom Iohexol could interact with their current medications (Metformin if serum creatinine >150μmol/L, Phenothiazines, Tricyclic antidepressants, Monoamine oxidase inhibitors, Levo-thyroxine, Amiodarone, Interleukin-2 agents) 4. People due to undergo an imaging scan using Tc99m –labelled agents within two weeks of the study; Iohexol can interfere with the measurement of Tc99m. 5. Patients on renal replacement therapy. 6. Individuals with a BMI outside the range 20-30Kg/m2 7. Individuals with ascites 8. Pregnant or breast-feeding women. 9. People who are unable to provide Informed Consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Glomerular Filtration Rate (GFR).
We will assess the performance of an Iohexol infusion (Method B) for the measurement of GFR in subjects with varying degrees of renal impairment and compare with a gold standard clearance of Iohexol (Method A). |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
IMP and comparator are Iohexol, i.e. the same drug |
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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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
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 | 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 the trial will be the date of the last blood test by the last participant. This is designated the Last Patient Last Visit (LPLV). |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |