ProteinuriaPhase 2N093NCT07355361
Huaier Granule and Proteinuria
A Phase 2 study testing Huaier Granule, Antitumor therapy and Proteinuria Management in people with Proteinuria and Breast Cancer Patients, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Proteinuria, Breast Cancer Patients
- What is being tested?
- Huaier Granule, Antitumor therapy and Proteinuria Management
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 15 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peng Ji, Dr. contact
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
JIPENG_1010@163.COM
About this study
Official title: 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:
Read more
- 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
- Being tested
- Huaier Granule, Antitumor therapy, Proteinuria Management
- Keywords
- proteinuria, Immunotherapy, Anti-angiogenic therapy, Breast cancer patients
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier GranuleDrug
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 therapyDrug
The pre-existing regimen started before enrollment, subject to adjustment based on clinical routine.
Proteinuria ManagementDrug
Specialist-managed care (including follow-up or drug therapy [excluding Huaier Granule]) initiated post-proteinuria diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| A Group | Active comparator | Antitumor therapy + Proteinuria management + Huaier Granule treatment Receives: Drug: Huaier Granule; Drug: Antitumor therapy; Drug: Proteinuria Management |
| B Group | Active comparator | Proteinuria management + Huaier Granule treatment Receives: Drug: Antitumor therapy; Drug: Proteinuria Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 8 weeks.
Secondary outcomes (4)
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)
Measured: From enrollment to the end of treatment at 16 weeks
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.
Measured: From enrollment to the end of treatment at 16 weeks
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.
Measured: From enrollment to the end of treatment at 16 weeks
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.
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteinuriaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhi-Ming Shao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355361
- Sponsor's protocol ID
- SCHBCC-N093
- Acronym
- N093
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Parallel-Controlled Clinical Trial on Huaier Granule for Proteinuria Associated With Immunotherapy and Anti-Angiogenic Therapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07355361
- Acronym / sponsor ID
- N093 / SCHBCC-N093
- Conditions
- Proteinuria, Breast Cancer Patients
- Keywords
- proteinuria, Immunotherapy, Anti-angiogenic therapy, Breast cancer patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A Group | Active comparator | Drug: Huaier Granule, Drug: Antitumor therapy, Drug: Proteinuria ManagementAntitumor therapy + Proteinuria management + Huaier Granule treatment |
| B Group | Active comparator | Drug: Antitumor therapy, Drug: Proteinuria ManagementProteinuria management + Huaier Granule treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inclusion Criteria
Key exclusion criteria (8 listed)
- Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier GranuleHuaier 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 | A Group |
| Antitumor therapyThe pre-existing regimen started before enrollment, subject to adjustment based on clinical routine. | Drug | A Group, B Group |
| Proteinuria ManagementSpecialist-managed care (including follow-up or drug therapy [excluding Huaier Granule]) initiated post-proteinuria diagnosis. | Drug | A Group, B Group |
Primary outcome
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.
4 secondary outcomes
Response rate of proteinuria treatment at Week 16
Time frame: 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
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
Other Renal Adverse Events at Weeks 8 and 16
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peng Ji, Dr. contact
Zhi-Ming Shao principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Huaier Granule, Antitumor therapy and Proteinuria Management in people with Proteinuria and Breast Cancer Patients, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Ming Shao, MD, PhD (+86-021-64175590, zhi_ming_shao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of proteinuria treatment at Week 8 (time frame: From enrollment to the end of treatment at 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.