Effect Camostat for Kidney Protection in Chronic Kidney Disease
ConditionChronic Kidney Disease(CKD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years.
eGFR ≥ 30 ml/min/1.73m2
U-ACR ≥ 300 mg/g.
Stable antihypertensive treatment 2 weeks before start of investigated medical drug (IMP) and maintain this treatment throughout the study.
Disqualifiers
Treatment with Amiloride, Spironolactone, Aldosterone, or analogues.
Treatment with NSAIDs.
Hyperkalemia > 5.0 mmol/L at screening.
P-bilirubin > 25 umol/L at screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Camostat Mesylate
DrugOral Camostat Mesylate 200 mg x 3 daily for 4 days.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Chronic Kidney Disease patientsExperimental treatment 1 intervention
Group B: Healthy ControlsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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).3
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).4
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).Secondary outcomes
1
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).2
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).3
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).4
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).Sponsors and contacts
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Source ClinicalTrials.gov