Actively Recruiting
Camostat Mesylate Treatment for Kidney Protection in Adults with Chronic Kidney Disease and Proteinuria Including Healthy Volunteers
Led by Odense University Hospital · Updated on 2025-01-27
40
Participants Needed
1
Research Sites
60 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Camostat Mesylate, a serine protease inhibitor, in adults with chronic kidney disease CKD who have proteinuria, a condition that worsens kidney damage and raises cardiovascular risks. This phase 2, open-label, non-randomized trial also includes healthy volunteers to compare the drugs impact on normal physiology versus CKD patients. The study aims to explore a new treatment target by assessing how Camostat Mesylate affects kidney function and related processes. Participants will follow a standardized sodium diet of 150 mmolday for eight days. From day 5 to day 8, they will take oral Camostat Mesylate at a dose of 200 mg three times daily. The study includes two groups patients with CKD and proteinuria, and healthy controls. Both groups will undergo the same treatment and dietary regimen to assess the drugs pharmacodynamic effects. Throughout the study, participants will provide blood and urine samples, record home blood pressure, and have body composition measured at baseline, before treatment, and after completing the four-day medication period. Researchers will measure urine sodium and water excretion, total body water, and blood pressure as primary outcomes. Secondary outcomes include markers of kidney tubular complement activation, urine protease activity, urine microvesicle analysis, and plasma concentrations of hormones related to kidney and cardiovascular function. The study will monitor participants until completion, with assessments timed precisely at days 0, 5, and 9.
CONDITIONS
Brief Title
Effect Camostat for Kidney Protection in Chronic Kidney Disease
Research Team
C
Claus Bistrup, MD, Professor
M
Mette B. Boes, MD
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