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
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of amiloride in adults with chronic kidney disease (CKD) and proteinuria. This randomized, placebo-controlled, double-blinded crossover trial aims to see if amiloride can protect the kidney's filtering barrier, reduce inflammation, lower albumin in the urine, and preserve kidney function. The study focuses on how amiloride might inhibit harmful processes independent of blood pressure changes. Participants receive amiloride 5 mg twice daily for 7 days or a matching placebo twice daily for 7 days, followed by a 2-3 week washout period before switching treatments. Blood and urine samples are collected before and after each treatment period. The study also monitors electrocardiograms, body composition, blood pressure, and body weight during the trial. Throughout the study, researchers measure urinary markers of kidney injury and inflammation, including urinary C3a, soluble C5-9, KIM-1, and NGAL. Secondary measures include urine albumin/creatinine and protein/creatinine ratios, along with home blood pressure readings. Participants are closely monitored for safety, and the total study duration involves two treatment periods separated by washout intervals.
CONDITIONS
Brief Title
Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older at the time of signing informed consent
- Clinical diagnosis of chronic kidney disease with eGFR between 25 and 60 mL/min/1.73m2 at screening
- Urine albumin to creatinine ratio (UACR) of 300 mg/g or higher at screening
- On stable antihypertensive treatment for at least 2 weeks before starting study drug and throughout study duration
- Office blood pressure between 110/60 mmHg and 150/90 mmHg at screening
- Capable of giving signed informed consent
- Women of childbearing potential must have negative pregnancy test at screening and use contraception during the study
You will not qualify if you...
- Treatment with amiloride alone or in combination or use of other potassium-sparing diuretics or mineralocorticoid receptor antagonists
- Ongoing cancer treatment
- Treatment with immunosuppressive therapy within 6 months prior to screening
- History of organ transplantation
- Current infection with CRP > 50 and temperature > 386C
- History of unstable or rapidly progressing renal disease with eGFR decreasing more than 5 mL/min/1.73m2 in past 2 months
- Severe hepatic insufficiency classified as Child-Pugh C
- Unstable or acute congestive heart failure or NYHA class IV
- Pregnancy or breastfeeding
- Recent cardiovascular events within 2 months prior to screening, including coronary artery revascularization, acute stroke, TIA, or acute coronary syndrome
- Risk of dehydration as judged by investigator
- Known hypersensitivity to study treatment or excipients
- Addison's disease
- Gastric bypass operation
- Participation in other interventional trials
- Lactose intolerance
- Plasma potassium greater than 4.9 mmol/l at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 7 weeks including treatment and washout periods
Participants receive amiloride 5mg or placebo twice daily for 7 days, followed by a 2 to 3 week washout period, then cross over to the other treatment for 7 days.
Visits before and after each 7-day treatment period
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
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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