Effect Camostat for Kidney Protection in Chronic Kidney Disease

Phase 2

Recruiting

• Conditions: Chronic Kidney Disease(CKD)
• Interventions: Drug: Camostat Mesylate

• Registration Number: NCT06794593
• Lead Sponsor: Odense University Hospital

Brief 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.

Detailed Description

Please refer to the protocol.

Study Timeline

• Study Start: 2024-11-21
• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chronic Kidney Disease patients	Camostat Mesylate	Patients with chronic kidney disease. eGFR \> 30 ml/min/1,73 m\^2 and U-ACR \> 300 mg/g.
Healthy Controls	Camostat Mesylate	Healthy males and females in good general health and with no significant medical conditions or chronic illness.

Primary Outcome Measures

Name	Time	Method
Total Body Water (L)	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).	Measured by Body Composition Monistor
Home blood pressure	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
24 h Urine sodium excretion (mmol/day)	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Water excretion (L)	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).	24 h urine collection

Secondary Outcome Measures

Name	Time	Method
Urine protease activity: zymography + protease activity	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Tubular complement activation	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).	Urine C3a, MAC-sC5b-9, C3dg, MBL
Urine microvesicles: gammaENaC cleavage	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)	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	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	At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).

Trial Locations

Locations (1)

Department of Nephrology, Odense University Hospital; 🇩🇰 Odense, Denmark