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NCT Number: NCT07355361

Huaier Granule and Proteinuria

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.

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Key information

Conditions

Proteinuria Breast Cancer Patients Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location contact

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • **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.
  • First-time detection of proteinuria on urinalysis, graded as +, ++, or +++.
  • 24-hour urinary protein quantification between 0.15g and 3.5g (exclusive).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Karnofsky Performance Status (KPS) score ≥70.
  • No prior treatment with Huaier Granule within one month before enrollment.
  • Life expectancy of at least 6 months.
  • Willingness to voluntarily participate in the study and provision of signed informed consent.

Exclusion criteria

  • **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).
  • Known allergy, contraindication, or specific precaution to any component of Huaier Granule.
  • Women who are pregnant, breastfeeding, or planning to conceive.
  • Concurrent participation in any other clinical trial investigating medications for proteinuria.
  • Any other condition that, in the judgment of the investigator, would make the patient unsuitable for participation in this study.

Treatment and study plan

Huaier granule

Drug

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.

Antitumor therapy

Drug

The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.

Proteinuria Management

Drug

Specialist-managed care (including follow-up or drug therapy [excluding Huaier Granule]) initiated post-proteinuria diagnosis.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Peng Ji, Dr.

CONTACT

[email protected]

Zhi-Ming Shao, MD, PhD

CONTACT

[email protected]

+86-021-64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: N093

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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