Actively Recruiting
Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
Led by Odense University Hospital · Updated on 2025-04-11
40
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older at the time of consent.
- Clinical diagnosis of chronic kidney disease with eGFR between 25 and 60 mL/min/1.73m2.
- Urine albumin to creatinine ratio (UACR) of 300 mg/g or higher at screening.
- Stable antihypertensive treatment for at least 2 weeks before and during the study.
- Office blood pressure between 110/60 mmHg and 150/90 mmHg at screening.
- Ability to give signed informed consent.
- Women with childbearing potential must have a negative pregnancy test at screening and use contraception during the study.
You will not qualify if you...
- Current treatment with amiloride alone or combined, or use of other potassium-sparing diuretics or mineralocorticoid receptor antagonists.
- Undergoing cancer treatment.
- Immunosuppressive therapy within 6 months prior to screening.
- History of organ transplantation.
- Current infection with CRP above 50 or temperature over 38°C.
- History of unstable or rapidly progressing kidney disease with recent eGFR decline.
- Severe liver failure classified as Child-Pugh C.
- Unstable blood pressure treatment less than 2 weeks before study drug start.
- Pregnancy or breastfeeding.
- Severe congestive heart failure or recent acute cardiac events within 2 months.
- Risk for dehydration as judged by the investigator.
- Known allergy to study treatments or resonium.
- Addison's disease.
- Gastric bypass surgery.
- Participation in other interventional trials.
- Lactose intolerance.
- Plasma potassium above 4.9 mmol/l at screening.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Nephrology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
G
Gitte Rye Hinrichs, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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