A Phase 2 interventional study of Camostat Mesylate in Chronic Kidney Disease(CKD), sponsored by Odense University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Odense University Hospital · Phase 2, Interventional, and Treatment
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:
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.
Please refer to the protocol.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's planned enrollment of 40 is below the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Odense University Hospital is the lead sponsor of 477 studies on the registry; 109 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients:
Inclusion criteria:
A clinical diagnosis of CKD of any course and meet the following criteria at screening:
Exclusion criteria:
Recent cardiovascular events \< 2 months prior to screening:
Healthy controls:
Inclusion criteria:
Normal kidney function and no proteinuria at screening:
7. Women with childbearing potential* must have a negative pregnancy test (urine hCG) at spot urine at the screening visit and should use contraception during the study and until one week after completion of study treatment.
Exclusion criteria:
Patients with chronic kidney disease. eGFR \> 30 ml/min/1,73 m\^2 and U-ACR \> 300 mg/g.
Drug: Camostat Mesylate
Healthy males and females in good general health and with no significant medical conditions or chronic illness.
Drug: Camostat Mesylate
Oral Camostat Mesylate 200 mg x 3 daily for 4 days.
Also known as: Foipan
24 h Urine sodium excretion (mmol/day)
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Water excretion (L)
24 h urine collection
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Total Body Water (L)
Measured by Body Composition Monistor
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Home blood pressure
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Urine protease activity: zymography + protease activity
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Tubular complement activation
Urine C3a, MAC-sC5b-9, C3dg, MBL
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Urine microvesicles: gammaENaC cleavage
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Urine microvesicles: complement deposition
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
24 hours urine albumin excretion (mg/day)
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Plasma concentration of renin, NT-proBNP, angiotensin II and aldosterone
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
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Studies of the drug tested here: Camostat
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