Chronic Kidney Disease(CKD)Phase 2CamKidNCT06794593
Effect Camostat for Kidney Protection in Chronic Kidney Disease
A Phase 2 study testing Camostat Mesylate in people with Chronic Kidney Disease(CKD), run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- What is being tested?
- Camostat Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Nov 2024to 28 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Nephrology, Odense University Hospital
Odense, 5000
Claus Bistrup, MD, Professor, +4523368077, Claus.Bistrup@rsyd.dk
Mette B Boes, MD, +4522919808, mette.boye.boes@rsyd.dk
About this study
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.
Read more
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.
Read the detailed description
Please refer to the protocol.
- Conditions
- Chronic Kidney Disease(CKD)
- Being tested
- Camostat Mesylate
- Keywords
- CKD, Chronic Kidney Disease, Proteinuria, Camostat Mesylate, Serine Protease Inhibitor, Complement, ENaC, Epithelial Sodium Channel, Albuminuria, Proteaseuria
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camostat MesylateDrug
Also called Foipan
Oral Camostat Mesylate 200 mg x 3 daily for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Kidney Disease patients | Experimental | Patients with chronic kidney disease. eGFR > 30 ml/min/1,73 m^2 and U-ACR > 300 mg/g. Receives: Drug: Camostat Mesylate |
| Healthy Controls | Experimental | Healthy males and females in good general health and with no significant medical conditions or chronic illness. Receives: Drug: Camostat Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 h Urine sodium excretion (mmol/day)
Measured: 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
Measured: 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
Measured: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Home blood pressure
Measured: 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
Measured: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Tubular complement activation
Urine C3a, MAC-sC5b-9, C3dg, MBL
Measured: 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
Measured: 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
Measured: 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)
Measured: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Plasma concentration of renin, NT-proBNP, angiotensin II and aldosterone
Measured: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start21 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claus Bistrup, MD, Professor, Study director, Department of Nephrology, Odense University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794593
- Sponsor's protocol ID
- EUCT 2023-508516-34-00
- Other IDs
- 2023-508516-34-00, 2023
- Acronym
- CamKid
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Camostat for Kidney Protection in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06794593
- Acronym / sponsor ID
- CamKid / EUCT 2023-508516-34-00
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- CKD, Chronic Kidney Disease, Proteinuria, Camostat Mesylate, Serine Protease Inhibitor, Complement, ENaC, Epithelial Sodium Channel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please refer to the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease patients | Experimental | Drug: Camostat MesylatePatients with chronic kidney disease. eGFR > 30 ml/min/1,73 m^2 and U-ACR > 300 mg/g. |
| Healthy Controls | Experimental | Drug: Camostat MesylateHealthy males and females in good general health and with no significant medical conditions or chronic illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years.
- A clinical diagnosis of CKD of any course and meet the following criteria at screening:
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camostat MesylateAlso: FoipanOral Camostat Mesylate 200 mg x 3 daily for 4 days. | Drug | Chronic Kidney Disease patients, Healthy Controls |
Primary outcome
24 h Urine sodium excretion (mmol/day)
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Water excretion (L)
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
24 h urine collection
Total Body Water (L)
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Measured by Body Composition Monistor
Home blood pressure
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
6 secondary outcomes
Urine protease activity: zymography + protease activity
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Tubular complement activation
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Plasma concentration of renin, NT-proBNP, angiotensin II and aldosterone
Time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claus Bistrup, MD, Professor study director
Department of Nephrology, Odense University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camostat Mesylate in people with Chronic Kidney Disease(CKD), run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claus Bistrup, MD, Professor (+4523368077, Claus.Bistrup@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 h Urine sodium excretion (mmol/day) (time frame: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.