NCT07704190Toborzás még nem indult4. fázis
Effect of Secukinumab on Cardiorenal Outcomes in Patients With Cardiorenal Metabolic Syndrome and Atherosclerotic Cardiovascular Disease
A Prospective, Randomized, Open-Label, Parallel-Controlled Study to Evaluate the Efficacy and Safety of Targeted Interleukin-17A (IL-17A) Inhibitor (Secukinumab) on Cardiovascular and Renal Endpoints in Patients With Cardiorenal Metabolic Syndrome Complicated With Atherosclerotic Cardiovascular Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 15.
Rövid összefoglaló (regiszter, angolul)
This is a prospective, randomized, open-label, parallel-controlled clinical trial to evaluate the efficacy and safety of targeted IL-17A inhibition with secukinumab on cardiovascular and renal endpoints in 100 patients with cardiorenal metabolic syndrome and atherosclerotic cardiovascular disease (ASCVD). Eligible subjects will be randomized 1:1 to receive either secukinumab 75 mg subcutaneous injection every 4 weeks for a total of 12 weeks plus standard guideline-directed medical therapy, or standard medical therapy alone. The primary endpoint is the time to first occurrence of 3-point major adverse cardiovascular events (MACE, including cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) over a 2-year follow-up period. Key indicators include estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR) for renal outcome assessment.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 4. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2026. júl. 6.
- Kezdés
- 2026. júl. 15.
- Elsődleges befejezés
- 2028. dec. 31.
- Fő szponzor
- Peking University Third Hospital
- NCT-szám
- NCT07704190
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 4. fázis
- Tervezett résztvevők: 100
- 2026. júl. 15. és az elsődleges befejezés (2028. dec. 31.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- History of myocardial infarction, stroke, transient ischemic attack, or hospitalization for unstable angina within 60 days prior to randomization.
- Major cardiac surgery, non-cardiac major surgery, or major endoscopy within 60 days before randomization, or planned major surgery during the study period.
- Current use of systemic immunosuppressive agents (glucocorticoids, small-molecule immunosuppressants, biologic DMARDs, anti-tumor drugs).
- Subjects with inadequate standard therapy judged by investigators.
Más betegség
- Clinical evidence or suspected active infection judged by investigators.
- History or confirmed evidence of active tuberculosis.
- History of inflammatory bowel disease.
- Active malignancy or carcinoma in situ within the past 5 years.
- Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg).
- Chronic heart failure classified as New York Heart Association (NYHA) Class IV.
- History of bone marrow or solid organ transplantation, or planned organ transplantation during the study.
- Known or suspected allergy to secukinumab or related excipients.
- Any disease condition that may endanger subject safety or impair protocol compliance per investigator judgment.
Laborértékek
- Absolute neutrophil count <2 ×10⁹/L or platelet count <120 ×10⁹/L, or alanine aminotransferase (ALT) / aspartate aminotransferase (AST) >2.5 × upper limit of normal.
- HbA1c ≥10% (≥86 mmol/mol).
Egyéb
- Planned coronary, carotid, or peripheral artery revascularization at randomization.
- Long-term intermittent hemodialysis or peritoneal dialysis.
- Pregnant, lactating females, or females of childbearing potential without adequate effective contraception.
Kiket keres a vizsgálat
- Age ≥ 18 years at screening.
- Meet at least one metabolic abnormality:
- Body mass index ≥ 23 kg/m²;
- Waist circumference ≥ 80 cm (female) or ≥ 90 cm (male);
- Fasting glucose 100-124 mg/dL (5.6-6.9 mmol/L) or glycated hemoglobin (HbA1c) 5.7-6.4%;
- Serum triglycerides ≥ 3.51 mmol/L;
- Documented hypertension, metabolic syndrome, or diabetes mellitus.
- Meet at least one diagnostic criterion for chronic kidney disease:
- eGFR ≥15 and <60 mL/min/1.73 m² (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine equation);
- UACR ≥ 200 mg/g with eGFR ≥ 60 mL/min/1.73 m² and documented albuminuria.
- Have documented atherosclerotic cardiovascular disease (at least one):
- Coronary heart disease: history of myocardial infarction, prior coronary revascularization, or ≥50% major epicardial coronary artery stenosis confirmed by cardiac catheterization or coronary coronary computed tomography angiography (CTA);
- Cerebrovascular disease: prior atherosclerotic stroke, prior carotid revascularization, or ≥50% carotid artery stenosis confirmed by imaging;
- Symptomatic peripheral artery disease.
- Able and willing to provide written informed consent.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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