Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on renal function and perfusion in 16 healthy subjects.
Analysis of the effect of i.v. VAS203 on renal function and perfusion in healthy subjects. Primary objective: Possible adverse effect of VAS203 on the Renal Plasma Flow (RPF) and the Glomerular Filtration Rate (GFR) during and after 6 hours of constant-rate iv. infusion of 10 mg/kg VAS203. Secondary objective: To analyse the effects of VAS203 on * filtration fraction * hemodynamics (afferent and efferent resistance, intraglomerular pressure) * markers of kidney injury and renal function * systolic, mean and diastolic brachial blood pressure * Plasma Pharmacokinetic of VAS203 and its first metabolite.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
16
Universitätsklinik Erlangen
Erlangen, Germany
Renal Plasma Flow
Renal plasma flow measurement by para-Amino-Hippuric-Acid Clearance Method
Time frame: 0, 2h, 4h, 6h and 8 h after start of infusion
Glomerular Filtration Rate
by para-Amino-Hippuric Acid Clearance Method
Time frame: 0, 2h, 4h, 6h and 8 h after start of infusion
Serum Creatinine Concentration
Time frame: 0, 2h, 4h, 6h, 8h, 10h, 24h and 48h after start of infusion
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