The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.
The monocenter randomized-controlled AMILOR trial investigates the efficacy of the ENaC blocker amiloride in reducing edema in nephrotic syndrome compared with standard therapy with the loop diuretic furosemide. Patients with acute nephrotic syndrome are randomized to receive amiloride (starting dose 5 mg) or furosemide (starting dose 40 mg) for 16 days. The target number of patients is n = 18 per arm. Exclusion criteria include GFR \<30ml/min/1.73m², AKIN 1 and 2, hypotension, hyper-/ hypokalemia, and hyponatremia. Overhydration is quantified by bioimpedance spectroscopy. Depending on the course of overhydration, dose adjustments (day 2, 5, 8, 12) or addition of HCT (day 8) are performed during the course of the study. Primary endpoint is decrease in overhydration at day 8, secondary endpoints include decrease in overhydration at day 16, as well as body weight, edema volume, blood pressure, urine volume, natriuresis at day 8 and 16, and need for dose adjustments and co-medication with HCT. Plasma potassium, sodium, and creatinine concentrations are measured as safety parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Treatment with amiloride, start dose 5 mg
Treatment with furosemide, start dose 40 mg
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Decrease of Overhydration, %ECW After 8 Days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Time frame: 8 days
Decrease of Overhydration, %ECW After 16 Days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Time frame: 16 days
Decrease of Body Weight, kg
Decrease of body weight after 8 days
Time frame: 8 days
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