A Crossover Pilot Study of the Effect of Amiloride on Proteinuria

  • STATUS
    Recruiting
  • End date
    Oct 9, 2021
  • participants needed
    30
  • sponsor
    Georgetown University
Updated on 9 February 2020
Investigator
Margie Dimatulac
Primary Contact
Georgetown University (7.9 mi away) Contact
+1 other location
glomerular filtration rate
nephropathy

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.

Description

Patients with proteinuric kidney disease will be enrolled and receive either amiloride or triamterene first, a similar diuretic acting on epithelial sodium channel (ENaC) as amiloride, but not inhibiting urokinase plasminogen activator receptor (uPAR), will be used as a control. Then patients will cross over to receive another medication. We postulate that amiloride could be beneficial in the patients with proteinuric kidney diseases and could be used as an adjunct therapy to reduce proteinuria and to delay renal disease progression in this patient population.

Specific Aim 1: To examine the effects of amiloride on 24 hour urine protein excretion in patients with proteinuric kidney diseases.

Specific Aim 2: To study if the effect of amiloride on proteinuria reduction is mediated by suppressing soluble urokinase plasminogen activator receptor (suPAR) expression.

Study Design:

The study includes 3 phases. 30 patients will be recruited to this study. All patients need to be on an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) daily at least two month prior to the study.

Phase 1: Patients will be randomized to receive either amiloride 5mg twice daily or triamterene 50mg twice daily for 8 weeks. Serum potassium will be monitored one week before and one week after starting phase 1. If serum potassium remains equal to or less than 5.0mmol/L, amiloride or triamterene will be continued at same dose until the end of phase 1. If serum potassium is equal to or above 5.5 mmol/L, the patient will exit the study, and an adverse event will be reported. If serum potassium is between 5.1-5.4 mmol/L, it will be monitored again in one week. If serum potassium is above 5.5 mmol/L, the patient will exit the study, and an adverse event will be reported. If serum potassium remains in the same range, the patient will continue amiloride or triamterene at the same dose to complete phase 1.

Phase 2: the patients will discontinue amiloride or triamterene for a washout for 4 weeks, but continue with the ACE inhibitor or ARB.

Phase 3: the patients will cross over to triamterene or amiloride for 8 weeks. Use the protocol as described in phase 1.

Details
Treatment Amiloride, Triamterene, Triamterene
Clinical Study IdentifierNCT02522650
SponsorGeorgetown University
Last Modified on9 February 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Proteinuria?
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
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