Using Camostat to Protect Kidneys in Chronic Kidney Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of Camostat Mesylate, a serine protease inhibitor, on patients with chronic kidney disease (CKD) and proteinuria. The study is designed as a non-randomized, open-label pharmacodynamic trial, including both CKD patients and healthy controls to assess the drug's impact on kidney function. Participants will follow a standardized sodium diet and receive Camostat Mesylate for four days while their kidney function and protein levels are monitored. The goal is to determine if this treatment can reduce kidney injury and improve clinical outcomes in CKD patients.

Why it matters

Who can join: the full rules

Patients:

Inclusion criteria:

1. Age ≥ 18 years.
2. A clinical diagnosis of CKD of any course and meet the following criteria at screening:

   1. eGFR ≥ 30 ml/min/1.73m2
   2. U-ACR ≥ 300 mg/g.
3. Stable antihypertensive treatment 2 weeks before start of investigated medical drug (IMP) and maintain this treatment throughout the study.
4. Office blood pressure at the screening session should be \>120/70 mmHg and \<150/90 mmHg.
5. Capable of providing a signed informed consent and comply with study requirements.
6. 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:

1. Treatment with Amiloride, Spironolactone, Aldosterone, or analogues.
2. Treatment with NSAIDs.
3. Hyperkalemia \> 5.0 mmol/L at screening.
4. P-bilirubin \> 25 umol/L at screening.
5. Ongoing cancer treatment.
6. Treatment with immunosuppressive therapy within 6 months prior to screening.
7. History of organ transplantation.
8. Evidence of current infection (CRP\>50 or temperature \> 38 C°).
9. Severe hepatic insufficiency classified as Child-Pugh C.
10. Breastfeeding.
11. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
12. Recent cardiovascular events \< 2 months prior to screening:

    1. Coronary artery revascularization.
    2. Acute stroke or TIA.
    3. Acute coronary syndrome.
13. Allergy or hypersensitivity to the IMP.
14. Addison's disease.
15. Gastric bypass operation.
16. Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP.
17. Participation in other clinical trials within the last 30 days.

Healthy controls:

Inclusion criteria:

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

   1. eGFR \> 90 ml/min/1.73m2
   2. U-ACR \< 30 mg/g
4. Office blood pressure at the screening \< 140/90 mmHg.
5. Capable of providing a signed informed consent and comply with study requirements.

7\. 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:

1. Treatment with any prescription medication except oral contraceptives.
2. Use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
3. Hyperkalemia \> 5.0 mmol/L at screening.
4. P-bilirubin \> 25 umol/L at screening.
5. Evidence of current infection (CRP\>50 or temperature \> 38 C°).
6. Breastfeeding.
7. History of substance abuse including alcohol.
8. Allergy or hypersensitivity to the IMP.
9. Gastric bypass operation.
10. Lactose intolerance since lactose serves as one of the inactive ingredients in the IMP.
11. Participation in other clinical trials within the last 30 days

Where it's running

• Department of Nephrology, Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Study coordinator: Claus Bistrup, MD, Professor
• Email: Claus.Bistrup@rsyd.dk
• Phone: +4523368077

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.