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Effect Camostat for Kidney Protection in Chronic Kidney Disease

NCT06794593 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-27

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Disease(CKD)

Interventions

DRUG

Camostat Mesylate

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

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Claus Bistrup, MD, Professor · Department of Nephrology, Odense University Hospital, Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-21
Primary Completion
2025-12-31
Completion
2027-02-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794593 on ClinicalTrials.gov