Recruiting

Amiloride

Sponsor:

Georgetown University

Code:

NCT02522650

Conditions

Proteinuria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Amiloride

Triamterene

Study Details

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

Study ID

NCT02522650

Start date

Jul, 2013

Status verified date

Feb, 2020

Completion date

Oct, 2021

Anticipated

Primary completion date

Oct, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amiloride Phase

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

active comparator: Triamterene Phase

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

no intervention: Washout Phase

Subject does not take any study medication for 4 weeks

Interventions

Amiloride

5mg twice a day for 8 weeks

Triamterene

50mg twice a day for 8 weeks

Primary outcome measure

  • 24 hr urine protein excretion [ Time Frame: 20 weeks ]

Central Contacts and Locations

Central contacts

Margie Dimatulac

202-444-1210mcd136@georgetown.edu

Locations

Georgetown University

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

Margie Dimatulac

202-444-1210mcd136@georgetown.edu.edu

MD

202-444-1089

Principal Investigator:

Wen Shen, MD, PhD

More Information

Sponsor

Georgetown University

Last update posted

Feb 7, 2020

Last verified

Feb, 2020

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2020-02-07.