Amiloride in Nephrotic Syndrome (NCT05079789) | Clinical Trial Compass
TerminatedPhase 3
Amiloride in Nephrotic Syndrome
Stopped: Low recruiting rate and decision to evaluate as pilot study
Germany20 participantsStarted 2020-06-08
Plain-language summary
The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Acute nephrotic syndrome with proteinuria \> 3 g/day and formation of edema.
✓. Age ≥ 18 years at the time of signing the informed consent.
✓. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
✓. Ability to adhere to the study visit schedule and other protocol requirements.
✓. Use of adequate thrombosis prophylaxis due to the increased risk of thrombosis in nephrotic syndrome and the expected fluctuations in volume balance during study participation.
✓. Subject (male or female) is willing to use highly effective methods of contraception according to the "Clinical trial fertility group" recommendations.
✓. Female Patients of childbearing potential (WOCBP) must agree to pregnancy testing before inclusion in the study.
✓. Female Patients must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
Exclusion criteria
✕. Severe reduction of kidney function: Creatinine clearance or calculated GFR \< 30 mL/min/1.73m² or acute kidney injury KDIGO stage 2 or 3 or anuria.