Proteinuria
Conditions
Keywords
Huaier Granules, Proteinuria, Bevacizumab, Anlotinib
Brief summary
This study is a prospective, multicenter, parallel-controlled clinical trial designed to evaluate the therapeutic efficacy of Huaier Granules for proteinuria occurring in lung cancer patients undergoing treatment with either Bevacizumab or Anlotinib.
Detailed description
This study is a prospective, multicenter, parallel-controlled exploratory trial. It plans to enroll 40 subjects diagnosed with malignant lung tumors, who will visit the selected research centers from October 2025 to October 2026. All subjects will be assigned to either the control group or the experimental group based on clinical management and their own preference. Subjects in the control group will receive no therapeutic intervention, while those in the experimental group will be administered Huaier Granules.Throughout the study period, the planned duration for subject recruitment and enrollment is 12 months. The total follow-up duration for enrolled subjects is 48 weeks. After enrollment, subjects will be followed up every 2 weeks during the first 8 weeks, and then every 4 weeks thereafter. Follow-ups will continue until the study ends, the subject withdraws from the study for any reason, is lost to follow-up, or dies, whichever occurs first.
Interventions
DRUGHuaier Granule
Take orally, 10g each time, three times daily.
DRUGAnlotinib and Bevacizumab
Administer according to clinical routine practice. Refer to the respective drug prescribing information for specific usage.
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years; * Histopathologically confirmed diagnosis of lung cancer; * Receiving Bevacizumab or Anlotinib treatment; * Positive urine protein detection, with 0.15g \< 24-hour urinary protein quantification \< 3.5g; * No treatment with Huaier Granules within one month prior to enrollment; * Expected survival time not less than 6 months; * Voluntary participation in this study and provision of signed informed consent.
Exclusion criteria
* Known allergy, contraindication, or caution to any component of Huaier Granules; * Inability to take oral medication; * Required or ongoing use of drugs known to potentially affect proteinuria, including but not limited to ACE inhibitors, glucocorticoids (\>3 weeks), and Chinese patent medicines (as per respective drug prescribing information); * Proteinuria caused by underlying diseases, including but not limited to nephropathy, hypertension, urinary tract infection, systemic lupus erythematosus, multiple myeloma, etc.; * Women who are pregnant, breastfeeding, or planning pregnancy; * Currently participating in other clinical trials investigating drugs for treating proteinuria; * Refusal to cooperate with follow-up; * Any other reasons deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 16-week Efficacy Rate for Proteinuria Treatment | Start of treatment until 16-week follow-up | It defined as the proportion of subjects achieving complete remission, partial remission, or stable disease according to proteinuria treatment efficacy evaluation at 16 weeks, relative to the total number of subjects in both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 48-week Recurrence Rate for Proteinuria Treatment | Start of treatment until 48-week follow-up | It defined as the proportion of subjects whose proteinuria reverts to positive (≥1+) after becoming negative during treatment, relative to the total number of subjects. |
| 48-week Resumption and Discontinuation Rates for Bevacizumab or Anlotinib after Proteinuria Treatment | Start of treatment until 48-week follow-up | It defined as the proportion of subjects who, due to worsening proteinuria, required temporary suspension of bevacizumab or anlotinib and subsequently resumed treatment after proteinuria alleviation, relative to the total number of subjects. |
| Incidence and Severity of Other Adverse Reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) after 48 weeks of Proteinuria Treatment | Start of treatment until 48-week follow-up | Incidence is defined as the proportion of subjects experiencing other adverse reactions (including but not limited to hypertension, bleeding, and gastrointestinal perforation) relative to the corresponding total population. Severity will be assessed as per the relevant descriptions in the adverse event definitions and evaluation section |
Countries
China
Contacts
CONTACTJialei Wang, phD
CONTACTXinmin Zhao, phD
PRINCIPAL_INVESTIGATORJialei Wang, phD
Fudan University
Outcome results
None listed