RecruitingPhase 2NCT06794593

Effect Camostat for Kidney Protection in Chronic Kidney Disease


Sponsor

Odense University Hospital

Enrollment

40 participants

Start Date

Nov 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called camostat — originally used for pancreatitis — can protect the kidneys in people with chronic kidney disease (CKD) who also have significant protein in their urine, which is a sign of kidney damage. **You may be eligible if...** - You are 18 or older with chronic kidney disease - Your kidney function (eGFR) is at least 30 mL/min and you have significant protein in your urine (albumin-to-creatinine ratio of 300 mg/g or more) - Your blood pressure is under control with stable medications for at least 2 weeks **You may NOT be eligible if...** - You are taking certain medications including NSAIDs, amiloride, or spironolactone - You have high potassium levels, significant liver problems, or an active infection - You are currently on cancer treatment or immune-suppressing therapy - You have had an organ transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamostat Mesylate

Oral Camostat Mesylate 200 mg x 3 daily for 4 days.


Locations(1)

Department of Nephrology, Odense University Hospital

Odense, Denmark

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NCT06794593


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