Amiloride in Nephrotic Syndrome

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    36
  • sponsor
    University Hospital Tuebingen
Updated on 20 October 2021
proteinuria

Summary

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

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/1.73m, 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.

Details
Condition Nephrotic Syndrome, Edema, swelling, oedema, Hypernatremia
Treatment Furosemide, Amiloride
Clinical Study IdentifierNCT05079789
SponsorUniversity Hospital Tuebingen
Last Modified on20 October 2021

Eligibility

Yes No Not Sure

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
All subjects must agree not to share medication

Exclusion Criteria

Severe reduction of kidney function: Creatinine clearance or calculated GFR < 30 mL/min/1.73m or acute kidney injury KDIGO stage 2 or 3 or anuria
Hypovolemia or dehydration
Uncontrolled diabetes mellitus
Hypotension, systolic blood pressure < 90 mmHg
Hyperkalemia, plasma potassium concentration > 4.8 mmol/l
Hypokalemia, plasma potassium concentration < 3.3 mmol/l
Hyponatremia, plasma sodium concentration < 128 mmol/l
Hypercalcemia, ionized calcium > 2.0 mmol/l or total albumin corrected calcium > 3.0 mmol/l
Signs of cardiac decompensation (orthopnoe, dyspnoe NYHA IV)
Hepatic coma or precoma
Symptoms of gout
Current therapy with potassium-sparing diuretics (e.g. spironolactone) or potassium supplements
Women during pregnancy and lactation
History of hypersensitivity to the investigational medicinal product, comparator or co-medication or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product, comparator or co-medication
Any other clinical condition that would jeopardize the patient's safety while participating in this clinical trial
Active participation in other clinical trials or observation period of competing trials
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