Amiloride in Nephrotic Syndrome — AMILOR  

Edema Clinical Trial

Official title: Randomized, Controlled Interventional Trial to Investigate the Efficacy of Amiloride for the Treatment of Edema in Human Nephrotic Syndrome

Status Terminated

Clinical Trial Summary

The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Edema
• Hypernatremia
• Nephrosis
• Nephrotic Syndrome
• Sodium Retention
• Syndrome

• NCT number: NCT05079789
• Study type: Interventional
• Source: University Hospital Tuebingen
• Status: Terminated
• Phase: Phase 3
• Start date: June 8, 2020
• Completion date: November 20, 2022