Amiloride in Nephrotic Syndrome

NCT05079789 | Terminated Phase 3 Results

• 2 other identifiers: AmiloridNS-012019-002607-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nephrotic Syndrome; Edema; Sodium Retention

Keywords

Nephrotic Syndrome; ENaC; Diuretic therapy; Amiloride; Proteasuria

Outcome Measures

Primary Outcomes (1)

• Decrease of Overhydration, %ECW After 8 Days

  Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)

  8 days

Secondary Outcomes (2)

• Decrease of Overhydration, %ECW After 16 Days

  16 days

• Decrease of Body Weight, kg

  8 days

Study Arms (2)

Amiloride

EXPERIMENTAL

Treatment wirh Amiloride, start dose 5 mg

Drug: Amiloride

Furosemide

ACTIVE COMPARATOR

Treatment with Furosemide, start dose 40 mg

Drug: Furosemide

Interventions

Amiloride DRUG

Treatment with amiloride, start dose 5 mg

Amiloride

Furosemide DRUG

Treatment with furosemide, start dose 40 mg

Furosemide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
• All subjects must agree not to share medication.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

• Artunc F, Worn M, Schork A, Bohnert BN. Proteasuria-The impact of active urinary proteases on sodium retention in nephrotic syndrome. Acta Physiol (Oxf). 2019 Apr;225(4):e13249. doi: 10.1111/apha.13249. Epub 2019 Jan 18.

  PMID: 30597733 BACKGROUND

Related Links

• Homepage working group Prof. Artunc

MeSH Terms

Conditions

Nephrotic Syndrome; Edema; Hypernatremia

Interventions

Amiloride; Furosemide

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Dr. Anja Schork
• Organization: University Hospital Tuebingen

Anja.Schork@med.uni-tuebingen.de

+49 707129 83172

Study Officials

• Ferruh Artunc, Prof., MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinincal Investigator, Project management

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: October 15, 2021
• Study Start: June 8, 2020
• Primary Completion: November 5, 2022
• Study Completion: November 20, 2022
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Locations

DE (1)