Amiloride in Nephrotic Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial

NCT02055872

Edema Hypoproteinemia

COMPLETED PHASE3

Increased Activity of a Renal Salt Transporter (ENaC) in Diabetic Kidney Disease

NCT01918488

Diabetic Nephropathies Hypertension

UNKNOWN NA

Extracellular Fluid in Resistant Hypertension

NCT00141596

Hypertension

TERMINATED NA

A New Application of Amiloride in the Treatment of Patient With Chronic Kidney Disease In Reducing Urinary PROtein

NCT03170336

Chronic Kidney Diseases

COMPLETED PHASE4

Protocolized Diuretic Strategy in Cardiorenal Failure

NCT01921829

Cardiac Failure Renal Failure Kidney Failure

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Nephrotic Syndrome Edema Sodium Retention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Amiloride

Treatment wirh Amiloride, start dose 5 mg

Group Type EXPERIMENTAL

Amiloride

Intervention Type DRUG

Treatment with amiloride, start dose 5 mg

Furosemide

Treatment with Furosemide, start dose 40 mg

Group Type ACTIVE_COMPARATOR

Furosemide

Intervention Type DRUG

Treatment with furosemide, start dose 40 mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Amiloride

Treatment with amiloride, start dose 5 mg

Intervention Type DRUG

Furosemide

Treatment with furosemide, start dose 40 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Acute nephrotic syndrome with proteinuria \> 3 g/day and formation of edema.
2. Age ≥ 18 years at the time of signing the informed consent.
3. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
4. Ability to adhere to the study visit schedule and other protocol requirements.
5. 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.
6. Subject (male or female) is willing to use highly effective methods of contraception according to the "Clinical trial fertility group" recommendations.
7. Female Patients of childbearing potential (WOCBP) must agree to pregnancy testing before inclusion in the study.
8. Female Patients must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
9. All subjects must agree not to share medication.

Exclusion Criteria

1. 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.
2. Hypovolemia or dehydration.
3. Uncontrolled diabetes mellitus.
4. Hypotension, systolic blood pressure \< 90 mmHg.
5. Hyperkalemia, plasma potassium concentration \> 4.8 mmol/l.
6. Hypokalemia, plasma potassium concentration \< 3.3 mmol/l.
7. Hyponatremia, plasma sodium concentration \< 128 mmol/l.
8. Hypercalcemia, ionized calcium \> 2.0 mmol/l or total albumin corrected calcium \> 3.0 mmol/l.
9. Signs of cardiac decompensation (orthopnoe, dyspnoe NYHA IV).
10. Hepatic coma or precoma.
11. Symptoms of gout.
12. Current therapy with potassium-sparing diuretics (e.g. spironolactone) or potassium supplements.
13. Women during pregnancy and lactation.
14. 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.
15. Any other clinical condition that would jeopardize the patient's safety while participating in this clinical trial.
16. Active participation in other clinical trials or observation period of competing trials.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No