Huaier Granule and Proteinuria
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University
About this trial
The goal of this clinical trial is to learn if adding Huaier Granule to standard care can treat proteinuria (excess protein in the urine) in adult female breast cancer patients (aged 18-75) who developed this condition as a side effect of their immunotherapy or anti-angiogenic cancer treatment.
The main question it aims to answer is:
\* Does the addition of Huaier Granule to standard care improve the effectiveness of proteinuria treatment after 8 weeks?
Researchers will compare the group receiving standard care plus Huaier Granule to the group receiving standard care alone to see if the combination is more effective at reducing protein levels in the urine.
Participants will:
* Be randomly assigned to one of the two study groups. * Continue their prescribed anti-cancer therapy (immunotherapy or anti-angiogenic therapy). * Receive standard medical care for proteinuria from a kidney specialist. * If in the experimental group, take Huaier Granule orally, three times a day. * Attend clinic visits every 4 weeks for up to 24 weeks for check-ups and tests, including urine and blood tests.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
**Inclusion Criteria**
Female patients aged 18-75 years.
Histopathologically confirmed diagnosis of breast cancer.
Currently receiving or having a prior history of immunotherapy and/or anti-angiogenic therapy.
Disqualifiers
**Exclusion Criteria**
Known history of chronic kidney disease (eGFR <60 ml/min/1.73m²) or diabetic nephropathy.
Proteinuria attributed to other diseases, including but not limited to primary renal disease, hypertension, urinary tract infection, systemic lupus erythematosus, or multiple myeloma.
Current use of ACEI/ARB medications (unless the dosage has been stable for ≥4 weeks prior to enrollment).
Trial design
Design model
Parallel
Treatments tested in this trial
Huaier Granule
DrugHuaier Granule Group: Participants will take Huaier Granule (Z20000109) on top of their standard treatment. The dosing is 10g, orally, three times a day. Treatment continues until the study ends, or an event such as disease progression, unacceptable side effects, withdrawal, or death occurs, whichever comes first. The investigator can also stop treatment if it's no longer deemed beneficial. Refer to the drug label for details. The investigator will decide on continued use if the background cancer therapy is changed due to progression.
Antitumor therapy
DrugThe pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.
Proteinuria Management
DrugSpecialist-managed care (including follow-up or drug therapy \[excluding Huaier Granule\]) initiated post-proteinuria diagnosis.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: A GroupActive comparator 3 interventions
Group B: B GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Response rate of proteinuria treatment at Week 8
The proportion of subjects (across both groups) achieving a best overall response of Complete Response, Partial Response, or Stable Disease in proteinuria at 8 weeks.
Time frame
From enrollment to the end of treatment at 8 weeks.Secondary outcomes
1
Response rate of proteinuria treatment at Week 16
Response rate at Week 16 (defined as the proportion of subjects with complete response, partial response, or stable disease in proteinuria)
Time frame
From enrollment to the end of treatment at 16 weeks2
Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16
The between-group difference in the mean change from baseline in 24-hour urinary protein quantification at Week 8.
Time frame
From enrollment to the end of treatment at 16 weeks3
Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16
The mean of the percentage change, which is calculated for each subject as: (Baseline 24-hour urinary protein value - Week 8 value) / Baseline value × 100%, averaged across all subjects in both the experimental and control groups.
Time frame
From enrollment to the end of treatment at 16 weeks4
Other Renal Adverse Events at Weeks 8 and 16
The incidence and severity of other renal adverse events (including but not limited to elevated blood pressure, increased serum creatinine, elevated blood urea nitrogen, acute kidney injury, nephritis, nephrotic syndrome, and renal failure) are defined as follows: Incidence is defined as the proportion of subjects experiencing any of the specified other renal adverse events within the respective total population. Severity will be graded according to the criteria described in the section for definitions and assessment of adverse events.
Time frame
From enrollment to the end of treatment at 16 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: