Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
amiloride: 5mg twice daily for 7 days
Placebo: 1 tablet twice daily for 7 days
Study summary
This is a randomized, placebo-controlled, double-blinded crossover trial testing the effects of amiloride in patients with chronic kidney disease (CKD) and proteinuria.
In CKD with proteinuria, there is aberrant filtration of serine proteases and complement precursors into the tubular lumen. The interaction of these factors leads to proinflammatory complement activation, which may promote inflammation, opsonization, and formation of the membrane-attack complex, causing cell injury.
With the aim of preserving kidney function, reducing cardiovascular morbidity, and delaying renal replacement therapy in CKD, this study tests whether amiloride (10 mg/day) protects the filtration barrier, lowers albuminuria, and mitigates kidney inflammation through urokinase inhibition, independent of blood pressure effects.
Participants are randomized to receive amiloride (10 mg/day) or placebo for one week, with a 2-3-week washout period in between. Blood and urine samples are collected before and after each treatment period. Additionally, ECG, body composition measurements, blood pressure, and body weight are monitored.
The primary outcome measures are urinary C3a, soluble C5-9 (sTCC/MAC), and kidney injury biomarkers KIM-1 and NGAL. Secondary endpoints include the urinary albumin/creatinine ratio, protein/creatinine ratio, and blood pressure.
Eligibility
Primary outcome measure(s)
- Urine-C3a (ng/ml) — Measured before (day one) and after (day 8) each treatment period
Urine-C3a is measured in spot urine samples and expressed as u-C3a/creatinine (µg/g) to account for the dilution factor. - Urine C5-9-sTCC/MAC (U/ml) — Measured before (day one) and after (day 8) each treatment period
Membrane Attack Complex (MAC) of the complement system, specifically targeting the C5 to C9 proteins. u-C5-9 is measured in spot urine samples and expressed as u-C5-9/creatinine U/µmol to account for the dilution factor. - Kidney Injury Molecule-1 (KIM-1) pg/ml — Measured before (day one) and after (day 8) each treatment period
KIM-1 is a protein that serves as a biomarker used particularly in the context of kidney injury - Neutrophil Gelatinase-Associated Lipocalin (NGAL) (pg/mL) — Measured before and after each treatment period
NGAL is a protein associated with neutrophils used as a biomarker in the context of kidney injury.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Nephrology, Odense University Hospital | Odense | Denmark | Recruiting |
More Odense University Hospital trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06923709 on ClinicalTrials.gov ↗ ← All trials in Denmark