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

January 21, 2025 updated by: Odense University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Please refer to the protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Department of Nephrology, Odense University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mette B Boes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chronic Kidney Disease patients
Patients with chronic kidney disease. eGFR > 30 ml/min/1,73 m^2 and U-ACR > 300 mg/g.
Drug: Camostat Mesylate
Oral Camostat Mesylate 200 mg x 3 daily for 4 days.
Other Names:
  • Foipan
Experimental: Healthy Controls
Healthy males and females in good general health and with no significant medical conditions or chronic illness.
Drug: Camostat Mesylate
Oral Camostat Mesylate 200 mg x 3 daily for 4 days.
Other Names:
  • Foipan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
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)
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
At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
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).
At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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 C3a, MAC-sC5b-9, C3dg, MBL
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).
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).
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).
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).
At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Odense University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Claus Bistrup, MD, Professor, Department of Nephrology, Odense University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EUCT 2023-508516-34-00
  • 2023-508516-34-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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