Effect of Camostat for Kidney Protection in Chronic Kidney Disease (CamKid).

Phase 1

Conditions: MedDRA version: 21.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857
Chronic Kidney Disease with proteinuria
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
MedDRA version: 20.1Level: PTClassification code: 10037032Term: Proteinuria Class: 100000004857

Registration Number: CTIS2023-508516-34-00

Lead Sponsor: Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age>18 years., A clinical diagnosis of CKD of any course and meet the following criteria at screening: a. eGFR > 30 ml/min/1.73m2 b. 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.

Exclusion Criteria

Treatment with Amiloride, Spironolactone, Aldosterone, or analogues., Breastfeeding., Congestive heart failure NYHA class IV, unstable or acute congestive heart failure., Recent cardiovascular events < 2 months prior to screening: a. Coronary artery revascularization. b. Acute stroke or TIA. c. Acute coronary syndrome., Allergy or hypersensitivity to the IMP., Addison’s disease., Gastric bypass operation., Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP., Participation in other clinical trials within the last 30 days., 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to evaluate the effect of Camostat mesilate on salt and water excretion including total body water content and blood pressure in patients with chronic kidney disease compared to healthy controls.;Secondary Objective: To evaluate the effect of Camostat mesilate on tubular serine protease activity and complement activation in patients with chronic kidney disease and proteinuria compared to healthy controls., To evaluate whether proteolytic activation of ENaC plays a role in normal physiological regulation.;Primary end point(s): Urine sodium excretion, Water excretion, Body Composition Monitor / weight, Home blood pressure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Urine protease activity: zymography + protease activity assay;Secondary end point(s):Tubular complement activation: Urine C3a, MAC-sC5b-9, C3dg, MBL;Secondary end point(s):Urine microvesicles: gammaENaC cleavage and complement deposition (sC5b-9);Secondary end point(s):24 hours urine albumin excretion;Secondary end point(s):Plasma concentration of renin, NT-proBNP, angiotensin II and aldosterone