NCT05079789

Amiloride in Nephrotic Syndrome

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Nephrotic Syndrome
• Edema
• Sodium Retention

Interventions

Type	Name	Description
DRUG	Amiloride	Treatment with amiloride, start dose 5 mg
DRUG	Furosemide	Treatment with furosemide, start dose 40 mg

Timeline

• Start date: 2020-06-08
• Primary completion: 2022-11-05
• Completion: 2022-11-20
• First posted: 2021-10-15
• Last updated: 2025-01-14
• Results posted: 2025-01-14

Locations

1 site across 1 country: Germany