Investigation of a low dose Iohexol infusion for the measurement of Glomerular Filtration Rate (GFR) in adult volunteers and patients with Chronic Kidney Disease. - Iohexol infusion as a measure of GFR

St. George's, University of London0 个研究点目标入组 35 人开始时间: 2010年8月6日最近更新: 2012年11月5日

适应症

试验速览

暂无简介。

•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

•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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