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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Odense University Hospital

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

30 Oct 2024 → 27 Feb 2026

Decision date (initial)

2024-03-18

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Efficacy, Therapy

The main objective is to evaluate the effect of Camostat mesilate on salt and water excretion including total body water content and blood pressure in patients with chronic kidney disease compared to healthy controls.

Secondary objectives 2

1. To evaluate the effect of Camostat mesilate on tubular serine protease activity and complement activation in patients with chronic kidney disease and proteinuria compared to healthy controls.
2. To evaluate whether proteolytic activation of ENaC plays a role in normal physiological regulation.

Conditions and MedDRA coding

Chronic Kidney Disease with proteinuria

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age>18 years.
2. A clinical diagnosis of CKD of any course and meet the following criteria at screening: a. eGFR > 30 ml/min/1.73m2 b. 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 17

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: a. Coronary artery revascularization. b. Acute stroke or TIA. c. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Urine sodium excretion
2. Water excretion
3. Body Composition Monitor / weight
4. Home blood pressure

Secondary endpoints 5

1. Urine protease activity: zymography + protease activity assay
2. Tubular complement activation: Urine total C3, C3a, C5a, MAC-sC5b-9, C3dg, MBL
3. Urine microvesicles: gammaENaC cleavage and complement deposition (sC5b-9)
4. 24 hours urine albumin excretion
5. Plasma concentration of renin, NT-proBNP, angiotensin II and aldosterone

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Odense University Hospital

Sponsor organisation

Odense University Hospital

Address

J B Winsloews Vej 4

City

Odense C

Postcode

5000

Country

Denmark

Scientific contact point

Organisation

Odense University Hospital

Contact name

Claus Bistrup

Public contact point

Organisation

Odense University Hospital

Contact name

Claus Bistrup

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications