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.
Conditions
Interventions
Trade Name: Iohexol (ONIPAQUE 300)
Product Name: Iohexol
Pharmaceutical Form: Intravenous infusion
Sponsors
St. George's, University of London
Eligibility
Sex/Gender
All
Inclusion criteria
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 (ß-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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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");Secondary Objective: There are none;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). | — |
Countries
United Kingdom
Outcome results
None listed