Huaier Granule and Proteinuria

NCT07355361 | Not Yet Recruiting Phase 2

• 1 other identifier: SCHBCC-N093
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proteinuria; Breast Cancer Patients

Keywords

proteinuria; Immunotherapy; Anti-angiogenic therapy; Breast cancer patients

Outcome Measures

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.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (4)

• Response rate of proteinuria treatment at Week 16

  From enrollment to the end of treatment at 16 weeks

• Change from baseline in 24-hour urinary protein quantification at Weeks 8 and 16

  From enrollment to the end of treatment at 16 weeks

• Mean percent reduction in 24-hour urinary protein quantification at Weeks 8 and 16

  From enrollment to the end of treatment at 16 weeks

• Other Renal Adverse Events at Weeks 8 and 16

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

A Group

ACTIVE COMPARATOR

Antitumor therapy + Proteinuria management + Huaier Granule treatment

Drug: Huaier Granule; Drug: Antitumor therapy; Drug: Proteinuria Management

B Group

ACTIVE COMPARATOR

Proteinuria management + Huaier Granule treatment

Drug: Antitumor therapy; Drug: Proteinuria Management

Interventions

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.

A Group

Antitumor therapy DRUG

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

A Group; B Group

Proteinuria Management DRUG

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

A Group; B Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 +++.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Proteinuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhi-Ming Shao

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi-Ming Shao, MD, PhD

CONTACT

+86-021-64175590; zhi_ming_shao@163.com

Peng Ji, Dr.

CONTACT

JIPENG_1010@163.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Breast Surgery Department

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)