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Evaluation of the potentially protective effect of Losartan in patients with carcinoma receiving VEGF signaling pathway inhibitors associated proteinuria: a randomized, blank control, intervention study

Evaluation of the potentially protective effect of Losartan in patients with carcinoma receiving VEGF signaling pathway inhibitors associated proteinuria: a randomized, blank control, intervention study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083385
Enrollment
Unknown
Registered
2024-04-23
Start date
2024-04-23
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

VEGF signaling pathway inhibitors associated proteinuria

Interventions

control group:Supportive therapy was given to observe changes in urinary protein
if new hypertension or existing hypertension was aggravated during the study, other types of antihypertensive drugs including CCB, ßblocker, ablocker or diuretic except renin vascular-angiotensin syst
New addition of SGLT-2 inhibitors, mineralocorticoid receptor antagonists were avoided during the study.
test group:Supportive therapy was given, with losartan potassium (50mg days, or 100mg / day), gradually titrated to the maximum tolerated dose (50mg / day, or 100mg / day) and remained stable. The pat

Sponsors

Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary signed informed consent form 2. Age: 18-75 years, no gender limit 3 Patients with a previously diagnosed malignancy 4 Patients being treated with VSPIs 5. One visit during the screening period: For patients with negative conventional albuminuria before VSPIs, 1 + was further followed by: a)0.3g <24 h urinary protein quantification (24HUTP)<1.5g; or b)0.3g/g <urinary protein to creatinine ratio (UPCR)<1.5g/g; a) and b) Prominuria was mainly albumin and globulin; or c) 300mg / g=urinary albumin to creatinine ratio (UACR)=1000mg / g For patients with positive conventional proteinuria before VSPIs, 1) conventional proteinuria increased from 1 + to 2 + or above; or 2) 24 HUTP or UPCR or UACR increased 25% from before treatment; 1) or 2) a) b) c) any of 3 6. Glomerular filtration rate [eGFR (CKD-EPI 2009)]=30ml/min/1.73m2

Exclusion criteria

Exclusion criteria: 1.Routine urine protein 2 + before using VSPIs; 2. Patients with acute kidney injury (AKI); 3. Other possible causes of proteinuria include systemic vasculitis, anti-GBM glomerulonephritis, monoclonal gammaglobulinemia of renal significance, IgG 4-associated nephritis, lupus nephritis, and other associated glomerular diseases (e. g., diabetic nephropathy). If proteinuria caused by other reasons cannot be excluded clinically, it should be clarified by kidney biopsy; 4. Patients who experienced any of the following cardiovascular events within 24 weeks: myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association Grade II heart failure, stroke, etc.; 5. Patients with renal artery stenosis; 6. Patients with hyperkalemia (blood potassium greater than 5.3 mmol/l); 7. Patients with low blood pressure (SBP 25 mmol/l); 12. Women born during pregnancy or lactation; 13. Subjects judged by the investigator for the study; 14. Patients with an estimated survival period of less than 1 year as judged by the investigator; 15. Allergy or known allergy or intolerance to any component of losartan potassium;16. Patients currently taking SGLT-2 inhibitors; 17. Patients taking mineralocorticoid receptor antagonists.

Design outcomes

Primary

MeasureTime frame
urine albumin-creatinine ratio;

Secondary

MeasureTime frame
urine protein to creatinine ratio;quantification of the 24-h urinary protein;estimated glomerular filtration rate;

Countries

China

Contacts

Public ContactMiaolin Che

Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China

drchemiaolin@126.com+86 136 6189 9350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026