NCT06794593RecruitingPhase 2
Effect Camostat for Kidney Protection in Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 10 Jan 2025
- Start date
- Nov 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Odense University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT06794593
- EU CT number
- 2023-508516-34-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From Nov 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with Amiloride, Spironolactone, Aldosterone, or analogues.
- Treatment with NSAIDs.
- Treatment with immunosuppressive therapy within 6 months prior to screening.
- Recent cardiovascular events \< 2 months prior to screening:
- Coronary artery revascularization.
- Acute stroke or TIA.
- Acute coronary syndrome.
- Treatment with any prescription medication except oral contraceptives.
- Use of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Other illness
- Ongoing cancer treatment.
- History of organ transplantation.
- Evidence of current infection (CRP\>50 or temperature \> 38 C°).
- Severe hepatic insufficiency classified as Child-Pugh C.
- Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
- Allergy or hypersensitivity to the IMP.
- Addison's disease.
- Evidence of current infection (CRP\>50 or temperature \> 38 C°).
- History of substance abuse including alcohol.
- Allergy or hypersensitivity to the IMP.
Lab values
- Hyperkalemia \> 5.0 mmol/L at screening.
- P-bilirubin \> 25 umol/L at screening.
- Hyperkalemia \> 5.0 mmol/L at screening.
- P-bilirubin \> 25 umol/L at screening.
Other
- Breastfeeding.
- 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:
- Breastfeeding.
- 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
Who the study is looking for
- 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.
- 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.
- 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.
Criteria the registry did not label
- Patients:
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.