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New treatment option for Chronic Kidney Disease(CKD)
Official title Effect Camostat for Kidney Protection in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06794593
What this study is testing
What is Camostat Mesylate?
Camostat Mesylate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic kidney disease(ckd).
Also referred to as Foipan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients:
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Patients:
- 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.
- 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. 7\. Women with childbearing potential\ must have a negative pregnancy test (urine hCG) at spot urine at the screening visit and should...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.