Effect Camostat for Kidney Protection in Chronic Kidney Disease

Please refer to the protocol.

Patients:

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Healthy controls:

Inclusion criteria

• Age ≥ 18 years.
• Good general health with no significant medical conditions or chronic illness (e.g., diabetes, hypertension, cardiovascular disease, autoimmune diseases, and cancer).
• Normal kidney function and no proteinuria at screening:

• eGFR > 90 ml/min/1.73m2
• U-ACR < 30 mg/g
• Office blood pressure at the screening < 140/90 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 any prescription medication except oral contraceptives.
• Use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
• Hyperkalemia > 5.0 mmol/L at screening.
• P-bilirubin > 25 umol/L at screening.
• Evidence of current infection (CRP>50 or temperature > 38 C°).
• Breastfeeding.
• History of substance abuse including alcohol.
• Allergy or hypersensitivity to the IMP.
• 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