Actively Recruiting
Effect of Oral Camostat Mesylate on Kidney Protection in Patients with Chronic Kidney Disease and Proteinuria A Pilot Interventional Study with Healthy Controls
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
Researchers are investigating the effects of Camostat Mesylate, a serine protease inhibitor, in patients with chronic kidney disease (CKD) and proteinuria. Proteinuria worsens CKD and increases cardiovascular risks. By blocking serine protease activity and tubular complement activation, Camostat may help reduce kidney damage and improve clinical outcomes. This is a phase 2, interventional, non-randomized, open-label pharmacodynamic trial including CKD patients with proteinuria and healthy controls to compare the drug's effects on diseased and normal physiology. Participants will follow a standardized sodium diet of 150 mmol/day for eight days. They will receive oral Camostat Mesylate at a dose of 200 mg three times daily for four days (days 5 to 8 of the diet). The study includes baseline measurements before treatment, assessments during treatment, and evaluations at study completion. Healthy controls and CKD patients will undergo the same procedures for comparison. Throughout the study, participants will provide blood and urine samples, record home blood pressure, and have body composition measured at baseline (day 0), before treatment (day 5), and after completing treatment (day 9). Researchers will measure urine sodium and water excretion, total body water, and other markers such as tubular complement activation, urine protease activity, and hormone levels. Safety and response to treatment will be closely monitored during the trial.
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
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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
M
Mette B. Boes, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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