A Crossover Pilot Study of the Effect of Amiloride on Proteinuria

NCT02522650 | Unknown Phase 4

• 1 other identifier: 2013-0496
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-over study is designed to test the hypothesis that amiloride will reduce urinary protein excretion and protect the kidney from rapid progression in proteinuric kidney disease.

Conditions

Proteinuria

Keywords

amiloride; proteinuric kidney disease; urokinase plasminogen activator receptor; proteinuria

Outcome Measures

Primary Outcomes (1)

• 24 hr urine protein excretion

  Identify changes in 24 hr urine protein excretion throughout the 3 phases of the study.

  20 weeks

Secondary Outcomes (4)

• urine plasmin activity

  20 weeks

• urine plasminogen activity

  20 weeks

• urine suPAR concentration

  20 weeks

• serum suPAR concentration

  20 weeks

Study Arms (3)

Amiloride Phase

EXPERIMENTAL

Subject receives 5mg of Amiloride twice daily for 8 weeks.

Drug: Amiloride

Triamterene Phase

ACTIVE COMPARATOR

Subject receives 50mg of Triamterene twice daily for 8 weeks.

Drug: Triamterene

Washout Phase

NO INTERVENTION

Subject does not take any study medication for 4 weeks

Interventions

Amiloride DRUG

5mg twice a day for 8 weeks

Amiloride Phase

Triamterene DRUG

50mg twice a day for 8 weeks

Triamterene Phase

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with any type of proteinuric kidney diseases
• Aged 18-75
• Proteinuria ≥1g/day
• estimated glomerular filtration rate (eGFR) ≥ 30ml/min/1.73m2

You may not qualify if:

• Clinical evidences of lupus nephritis, or HIV associated nephropathy
• eGFR \<30ml/min/1.73m2
• Requirement for treatment with mineralocorticoid receptor antagonists (spironolactone, eplerenone)
• Status post kidney transplant
• Received glucocorticoid steroids within six months
• Serum K \>4.8 mmol/L
• Total carbon dioxide \<17 mmol/L
• Hemoglobin \<10 g/dl
• Contraindicated or allergic to loop diuretics or potassium sparing diuretics
• Abnormal liver function tests

Sponsors & Collaborators

• Georgetown University: lead

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Related Publications (31)

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  PMID: 33957621 DERIVED

MeSH Terms

Conditions

Proteinuria

Interventions

Amiloride; Triamterene

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wen Shen, MD, PhD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margie Dimatulac

CONTACT

202-444-1210; mcd136@georgetown.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 23, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2013
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 7, 2020

Record last verified: 2020-02

Locations

US (1)