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NETs

Recruiting

Impact of Antiglycemic & Immunosuppressive Therapies on NETosis in Diabetes & Kidney Disease (NETs - Neutrophil Traps)

Evaluating the Effect of Hemodialysis Modality and New Anti-glycemic Drugs on NETosis on in Hemodialysis and Diabetic Patient, and Assessment of NETosis in Various Kidney Diseases

Lead sponsor

Western Galilee Hospital-Nahariya

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Chronic kidney disease, Diabetes (other / unspecified), Healthy volunteers

Key I/E criterion

—

Primary endpoints

•NETosis marker- citrullinated histone H3 (citH3)•NETosis marker- Myeloperoxidase•NETosis marker- Neutrophil elastase (NE)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06821919

Org study ID0108-22-NHR

Timeline

Milestones

Study start2024-05-13actual

Study first posted2025-02-12actual

Last update posted2025-02-12actual

Primary completion2030-12-30estimated

Study completion2031-12-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseDiabetes (other / unspecified)Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Sampling methodNon probability sample

Study population text

DM therapy study: - Diabetic patients aged 18 years or older (men and women). * Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists. • Exclusion Criteria: * Patients with conditions affecting NETosis, including autoimmunity, hematologic or oncologic diseases, or positive for HIV or Hepatitis B/C. Chronic kidney disease (CKD) patients :This study will include 50 CKD patients with various etiologies, with a focus on those with immune-mediated kidney diseases, such as ANCA-associated vasculitis. The primary aim is to evaluate the effects of immunosuppressive therapy on NETosis. All patients will be naïve to prior immunosuppressive therapy to ensure the observed effects are directly attributable to the initiation of treatment. • Exclusion Criteria: o Patients with acute infections, hematologic or oncologic diseases, or positive for HIV or Hepatitis B/C

Eligibility criteria

DM therapy study: - Diabetic patients aged 18 years or older (men and women).

•Patients who have not previously received SGLT2 inhibitors or GLP-1 receptor agonists.

-Chronic kidney disease (CKD) patients :50 CKD patients with various etiologies.

• Focus:

•This part of the study will specifically evaluate immune-mediated kidney disease, such as ANCA-associated vasculitis, and the effects of immunosuppressive therapy on NETosis.

• Exclusion Criteria:

•Patients with acute infections, hematologic or oncologic diseases, or positive for HIV or Hepatitis B/C

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiovascular outcomes

Renal / kidney

Cardiometabolic biomarkers

Cardiovascular outcomes

2 endpoints

Secondary/protocol endpoint

Major adverse cardiovascular events (MACE)

Time frame:1,2 , 3, 6 and 12 months, and each year (during 5 years) after starting anti-diabetic drugs or immunosuppression therapy

4-point MACE

composite event, event

componentsMyocardial infarction (any), Stroke (any), Heart-failure hospitalization, Cardiovascular death

Secondary/protocol endpoint

All cause mortality

Time frame:1,2 , 3, 6 and 12 months, and each year (during 5 years) after starting anti-diabetic drugs or immunosuppression therapy

All-cause death

time to event, event

SNOMED 419620001

Renal / kidney

2 endpoints

Secondary/protocol endpoint

Kidney function

Time frame:Before treatment, 1,2 , 3, 6 and 12 months, and each year (during 5 years) after starting anti-diabetic drugs or immunosuppression therapy.

eGFR, change

change from baseline, improvement

LOINC 98979-8

Secondary/protocol endpoint

Urine protein/ creatinine ratio

Time frame:Before treatment, 1,2 , 3, 6 and 12 months, and each year (during 5 years) after starting anti-diabetic drugs or immunosuppression therapy

ratio, improvement

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

NETosis marker- Neutrophil elastase (NE)

Time frame:Before treatment, 1,2 , 3, 6 and 12 months after starting anti-diabetic drugs or immunosuppression

concentration, descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

NETosis marker- citrullinated histone H3 (citH3)

Time frame:Before treatment, 1,2 , 3, 6 and 12 months after starting anti-diabetic drugs or immunosuppression

descriptive

Primary/protocol endpoint/low confidence

NETosis marker- Myeloperoxidase

Time frame:Before treatment, 1,2,3,6 and12 moths after treatment.

concentration, descriptive

Primary/protocol endpoint/low confidence

NETosis marker: Peptidylarginine deiminase 4-PAD4

Time frame:Before treatment, 1,2 , 3, 6 and 12 months after starting anti-diabetic drugs or immunosuppression

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.