Huaier Granule and Proteinuria (N093)

January 13, 2026 updated by: Zhimin Shao, Fudan University

Multicenter, Randomized, Parallel-Controlled Clinical Trial on Huaier Granule for Proteinuria Associated With Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • **Inclusion Criteria**

    1. Female patients aged 18-75 years.
    2. Histopathologically confirmed diagnosis of breast cancer.
    3. Currently receiving or having a prior history of immunotherapy and/or anti-angiogenic therapy.
    4. First-time detection of proteinuria on urinalysis, graded as +, ++, or +++.
    5. 24-hour urinary protein quantification between 0.15g and 3.5g (exclusive).
    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    7. Karnofsky Performance Status (KPS) score ≥70.
    8. No prior treatment with Huaier Granule within one month before enrollment.
    9. Life expectancy of at least 6 months.
    10. Willingness to voluntarily participate in the study and provision of signed informed consent.

Exclusion Criteria:

  • **Exclusion Criteria**

    1. Known history of chronic kidney disease (eGFR <60 ml/min/1.73m²) or diabetic nephropathy.
    2. Proteinuria attributed to other diseases, including but not limited to primary renal disease, hypertension, urinary tract infection, systemic lupus erythematosus, or multiple myeloma.
    3. Current use of ACEI/ARB medications (unless the dosage has been stable for ≥4 weeks prior to enrollment).
    4. Known allergy, contraindication, or specific precaution to any component of Huaier Granule.
    5. Women who are pregnant, breastfeeding, or planning to conceive.
    6. Concurrent participation in any other clinical trial investigating medications for proteinuria.
    7. Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A Group
Antitumor therapy + Proteinuria management + Huaier Granule treatment
Drug: Huaier Granule
Huaier 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.
Drug: Antitumor therapy
The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.
Drug: Proteinuria Management
Specialist-managed care (including follow-up or drug therapy [excluding Huaier Granule]) initiated post-proteinuria diagnosis.
Active Comparator: B Group
Proteinuria management + Huaier Granule treatment
Drug: Antitumor therapy
The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.
Drug: Proteinuria Management
Specialist-managed care (including follow-up or drug therapy [excluding Huaier Granule]) initiated post-proteinuria diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of proteinuria treatment at Week 8
Time Frame: From enrollment to the end of treatment at 8 weeks.
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.
From enrollment to the end of treatment at 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate of proteinuria treatment at Week 16
Time Frame: From enrollment to the end of treatment at 16 weeks
Response rate at Week 16 (defined as the proportion of subjects with complete response, partial response, or stable disease in proteinuria)
From enrollment to the end of treatment at 16 weeks
Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16
Time Frame: From enrollment to the end of treatment at 16 weeks
The between-group difference in the mean change from baseline in 24-hour urinary protein quantification at Week 8.
From enrollment to the end of treatment at 16 weeks
Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16
Time Frame: From enrollment to the end of treatment at 16 weeks
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.
From enrollment to the end of treatment at 16 weeks
Other Renal Adverse Events at Weeks 8 and 16
Time Frame: From enrollment to the end of treatment at 16 weeks

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.
From enrollment to the end of treatment at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Zhi-Ming Shao, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

June 15, 2028

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHBCC-N093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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