Actively Recruiting
Effect Camostat for Kidney Protection in Chronic Kidney Disease
Led by Odense University Hospital · Updated on 2025-01-27
40
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial aims to evaluate the effects of Camostat Mesylate, a serine protease inhibitor, in patients with chronic kidney disease (CKD) and proteinuria. Proteinuria accelerates CKD progression and increases cardiovascular risks. By inhibiting serine protease activity and tubular complement activation, camostat may mitigate progressive kidney injury, potentially improving clinical outcomes. This is an interventional, non-randomized, open-label pharmacodynamic trial that includes CKD patients with proteinuria and healthy controls. This approach has been chosen as the trial serves as a pilot study, aiming to investigate a novel treatment target in CKD patients. Including healthy controls allows a comparison of the effect of Camostat Mesilate on normal physiology versus CKD with proteinuria. Participants will: * Follow a standardized sodium diet of 150 mmol/day for 8 days. * Receive oral Camostat Mesilate (200 mg thrice daily) for four days (day 5-8 on the diet). * Provide blood and urine samples, record blood pressure, and undergo body composition measurements at baseline, during intervention, and at study completion. The primary effect parameters are urine sodium and water excretion, body water content/weight, and home blood pressure. Secondary endpoints are tubular complement activation, urine protease activity, ENaC activation, 24-hour urine albumin excretion, and plasma concentrations of renin, angiotensin II, aldosterone, and NT-proBNP.
CONDITIONS
Official Title
Effect Camostat for Kidney Protection in Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of CKD with eGFR of at least 30 ml/min/1.73m2 and urine albumin-to-creatinine ratio (U-ACR) of 300 mg/g or higher
- Stable antihypertensive treatment for at least 2 weeks before starting the study drug and throughout the study
- Office blood pressure between 120/70 mmHg and 150/90 mmHg at screening
- Ability to provide signed informed consent and comply with study requirements
- For women with childbearing potential: negative pregnancy test at screening and use of contraception during the study and until one week after treatment completion
- Good general health with no significant medical conditions or chronic illness for healthy controls
- Normal kidney function (eGFR above 90 ml/min/1.73m2) and no proteinuria (U-ACR below 30 mg/g) for healthy controls
- Office blood pressure below 140/90 mmHg for healthy controls
You will not qualify if you...
- Treatment with Amiloride, Spironolactone, Aldosterone or analogues
- Use of NSAIDs
- Hyperkalemia greater than 5.0 mmol/L at screening
- Elevated bilirubin (P-bilirubin above 25 umol/L) at screening
- Ongoing cancer treatment
- Immunosuppressive therapy within 6 months prior to screening
- History of organ transplantation
- Current infection indicated by CRP above 50 or fever above 38°C
- Severe liver failure classified as Child-Pugh C
- Breastfeeding
- Congestive heart failure NYHA class IV or unstable/acute heart failure
- Recent cardiovascular events within 2 months prior to screening, including coronary revascularization, acute stroke, TIA, or acute coronary syndrome
- Allergy or hypersensitivity to Camostat Mesylate
- Addison's disease
- Gastric bypass surgery
- Lactose intolerance
- Participation in other clinical trials within the last 30 days
- For healthy controls: treatment with any prescription medication except oral contraceptives
- History of substance abuse including alcohol for healthy controls
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Nephrology, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
C
Claus Bistrup, MD, Professor
CONTACT
M
Mette B. Boes, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here