Effect Camostat for Kidney Protection in Chronic Kidney Disease

NCT06794593 | Recruiting Phase 2

• 2 other identifiers: EUCT 2023-508516-34-002023-508516-34-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease(CKD)

Keywords

CKD; Chronic Kidney Disease; Proteinuria; Camostat Mesylate; Serine Protease Inhibitor; Complement; ENaC; Epithelial Sodium Channel; Albuminuria; Proteaseuria

Outcome Measures

Primary Outcomes (4)

• 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)

  24 h urine collection

  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

  At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).

• Home blood pressure

  At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).

Secondary Outcomes (6)

• 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 microvesicles: gammaENaC cleavage

  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).

• 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).

Study Arms (2)

Chronic Kidney Disease patients

EXPERIMENTAL

Patients with chronic kidney disease. eGFR \> 30 ml/min/1,73 m\^2 and U-ACR \> 300 mg/g.

Drug: Camostat Mesylate

Healthy Controls

EXPERIMENTAL

Healthy males and females in good general health and with no significant medical conditions or chronic illness.

Drug: Camostat Mesylate

Interventions

Camostat Mesylate DRUG

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

Also known as: Foipan

Chronic Kidney Disease patients; Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• A clinical diagnosis of CKD of any course and meet the following criteria at screening:
• 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.
• Office blood pressure at the screening session should be \>120/70 mmHg and \<150/90 mmHg.
• Capable of providing a signed informed consent and comply with study requirements.
• 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.

You may not qualify if:

• Treatment with Amiloride, Spironolactone, Aldosterone, or analogues.
• Treatment with NSAIDs.
• Hyperkalemia \> 5.0 mmol/L at screening.
• P-bilirubin \> 25 umol/L at screening.
• Ongoing cancer treatment.
• Treatment with immunosuppressive therapy within 6 months prior to screening.
• History of organ transplantation.
• Evidence of current infection (CRP\>50 or temperature \> 38 C°).
• Severe hepatic insufficiency classified as Child-Pugh C.
• Breastfeeding.
• Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
• Recent cardiovascular events \< 2 months prior to screening:
• Coronary artery revascularization.
• Acute stroke or TIA.
• Acute coronary syndrome.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Nephrology, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria; Albuminuria

Interventions

camostat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• Claus Bistrup, MD, Professor

  Department of Nephrology, Odense University Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Claus Bistrup, MD, Professor

CONTACT

+4523368077; Claus.Bistrup@rsyd.dk

Mette B. Boes, MD

CONTACT

+4522919808; mette.boye.boes@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-center, interventional, non-randomized, open-label pharmacodynamic study designed to evaluate the effects of Camostat Mesilate in patients with chronic kidney disease (CKD) and proteinuria compared to healthy controls. A total of 40 participants (20 CKD patients and 20 healthy controls matched by age and gender) will follow a standardized sodium diet (150 mmol/day) for 8 days. On the fifth day, participants will begin a 4-day course of oral Camostat (200 mg three times daily), while continuing the sodium-controlled diet. CKD patients will receive CM as an add-on to their standard treatment. Blood samples, 24-hour urine collections, home blood pressure measurements, and body composition monitoring will be performed at baseline, after 4 days on the diet, and after completing the Camostat treatment.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 27, 2025
• Study Start: November 21, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

DK (1)